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Bronze Level Contributor

The healthcare industry is accelerating adoption of artificial intelligence technologies, helping boost the total AI software market six times by 2025, analyst firm Omdia said Wednesday.

Even so, COVID-19 has taken a toll on the overall AI software market with retrenchment in industries such as energy, oil, gas and mining.

The firm put the overall AI software market at $16.4 billion in 2019 and expects it will grow to nearly $99 billion by 2025 under a moderate growth scenario.

Based on the duration of the COVID-19 pandemic, Omdia has developed four market scenarios with the $99 billion forecast considered a moderate scenario with double digit annual growth ahead.  This moderate scenario is down by 22% when compared to pre-COVID forecasts, however.

The firm’s most pessimistic forecast says AI software revenues will only reach $50 billion by 2025, while the most optimistic forecast reaches $130 billion by 2025.

Omdia follows 340 different AI use cases across 23 industries.  The use cases include voice and speech recognition, video surveillance, customer service and marketing virtual digital assistants, network operations monitoring and management and supply chain and inventory management.

The pandemic effect will hit industries differently depending on how far along companies have progressed in adopting AI, said Omdia senior analyst Neil Dunay.  Industries with the largest AI investments will continue to invest because they see the AI software as indispensable for cost cutting, revenue generation and enhancing customer interactions.

Despite its impact, Omdia said that AI software remains a relatively small portion of overall software sales.

Originally published by
Matt Hamblen | Jul 8, 2020
Fierce Electronics

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Bronze Level Contributor

As COVID-19 roiled financial markets in the first half of the year, private investors poured $5.4 billion into digital health startups, the largest investment in the sector for the period over the past decade, according to a new midyear report from Rock Health.

The research firm and venture fund reversed its earlier prediction that the pandemic would dampen access to capital in the digital health space and now expects records to be set this year for overall funding, number of deals and deal size.

The easing of regulatory and reimbursement barriers to digital health adoption, intended to support healthcare systems during the public health crisis, rekindled investor interest in May and June after a pause at the onset of the virus outbreak, Rock Health said in the report released Monday.

Investment in the digital health sector was off to a strong start in 2020 at a record $3 billion in the first quarter alone, before momentum stalled in March and April. The halt in activity as COVID-19 spread quickly around the globe, however, did not last long. Rock Health notes that of 11 large deals valued at $100 million or more in the first half, five occurred in May and June, when the outbreak and resulting U.S. economic downturn were well underway.

Funding for digital health companies in the second quarter was $2.4 billion, 33% above the $1.8 billion quarterly average for the prior three years. The average size of a deal in the first half of 2020 was $25.1 million, easily topping the previous record of $21.5 million in 2018.

The most popular areas for investment included on-demand healthcare services, disease monitoring and behavioral health.

Among the biggest medical device deals were $125 million in financing for Outset Medical, which makes a connected dialysis system, and $146 million to wearable defibrillator maker Element Science.

Top funding beneficiaries across other sectors were prescription delivery service Alto Pharmacy ($250 million); telehealth services company Amwell ($194 million); AI-driven drug discovery platform Insitro ($143 million); on-demand urgent care company DispatchHealth ($136 million); and evidence-based therapy and psychiatry platform Mindstrong Health ($100 million).

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Originally published by
Susan Kelly | July 7, 2020
Health Care Dive

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Bronze Level Contributor

Toronto-based Perimeter Medical Imaging wants to make breast conservation surgeries more efficient by combining an optical coherence tomography device with an AI engine to reduce the number of repeat surgeries required.

The possibility of repeat surgeries to remove cancer from women diagnosed with breast cancer is a reality of breast conservation surgery. In the U.S. about 25 percent of women need additional surgery after a lumpectomy, which is done to preserve breast tissue after an initial breast cancer diagnosis.

This is because, following a lumpectomy after which the patient is sent home, a pathologist’s report days or weeks later may find cancer at the margins of the excised breast tissue. And that positive margin means the patient has to undergo another surgery to fully remove cancer or undergo a full mastectomy. All of which is emotionally taxing for patients.

“They trust their surgeon that they are going to remove it and it’s a very difficult phone call that the surgeon has to make to the patient to say ‘I missed some of the cancer, so you have to come back for a surgery.'” said Andrew Berekely, co-founder of Perimeter Medical Imagine a Toronto startup that is developing an AI-powered solution to the problem of repeat breast cancer surgery. “That’s not a phone call that surgeons like to make.”

Perimeter Medical went public in a reverse takeover of a public company this week and is expected to start trading on the TSX Venture Exchange in Canada on July 6. The company raised private capital of C$10 million (about $7.3 million) from investors including Roadmap Capital, shareholders of the public company it took over and high net worth people. Perimeter Medical has also received a $7.4 million grant from the Cancer Prevention and Research Institute of Texas, according to Berkeley. The company has its U.S. offices in Dallas.

The technology that Perimeter hopes to commercialize includes a medical device that can perform optical coherence tomography (OCT) on excised breast tissue and then feed that imaging data into its AI engine to determine whether the margin is positive – in other words, does the tissue in the margins contain cancer. That real-time information can help to determine whether the surgeon needs to take out more of the breast tissue thereby perhaps reducing the chance of another surgery down the road.

“The OCT is used to scan the back of your eye which is a 1 cm area. We have adapted the technology to scan very large complex surfaces like a removed tissue specimen in a very fast amount of time and give information back in the operating room where it is a time-sensitive situation …,” Berkeley said.

That fast turnaround will be powered by the AI engine.

“We have custom-built machine learning algorithms specifically for OCT that are specifically trained on breast tissue and this is years worth of working and selecting clinical data. What we do is that we image the tissue and then we take the post-operative pathology – what the pathologist looks at under the microscope — and we do what’s called a correlation,” he explained. “So we take the exact same area [that a pathologist finds] when they see tissue under the microscope, [and] we can go back to the same area in the images and we label in our images what disease looks like and we feed that into the ML algorithm and the more we do that the better it gets at identifying new diseases.”

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Originally published by
Arundhati Parmar | July 2, 2020
MedCity News

 

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Gold Level Contributor

Digital surgery platform developer Brainlab is taking a leap into developing medical video games—designed not for patients, but for surgeons.

The German maker of planning, navigation and robotic tools for neurological and orthopedic procedures as well as hardware for radiation surgery has acquired Level Ex, a Chicago-based developer of software programs aimed at clinicians.

Level Ex’s portfolio includes smartphone apps that test skills in cardiology, pulmonology, gastroenterology and anesthesiology. This can include diagnosing an ailment and selecting the proper course of treatment before time runs out or performing virtual airway procedures. Completing the games can also grant continuing medical education credits.

Brainlab says it has already begun to integrate Level Ex’s digital work across its more tangible product portfolio. This includes its use as a virtual sales tool for the company’s X-ray patient positioning and monitoring offerings as well as connecting it with 3D surgical viewing software.

“We began working with Level Ex in 2019 for several reasons,” said Brainlab President and CEO Stefan Vilsmeier. “They are the best at disseminating best practices through video games, and they are unrivaled in their level of ergonomic user interaction, gaming-industry-quality 3D graphics, precise physics models and game mechanics psychology.”

The financial details of the acquisition were not disclosed. Going forward, Brainlab said it plans to help Level Ex expand its team and move into global markets, including through additional partnerships with medical device companies, drugmakers and medical societies.

The developer also plans to release new games in dermatology, orthopedics and oncology over the next year. Additionally, Level Ex will maintain its brand and operate independently of Brainlab.

“Our mission is to advance the practice of medicine through play: unleashing video game technology and design to improve skill and accelerate the adoption curve of new techniques and technologies in healthcare,” said Sam Glassenberg, founder and CEO of Level Ex, which counts a user base of more than 600,000 medical professionals and students.

The 105-person company is also working with NASA to help build an astronaut medical training program through a grant from the Translational Research Institute for Space Health.

Originally published by
Conor Hale | June 29, 2020
Fierce Biotech

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Bronze Level Contributor

Pixabay

Israeli research lab JSOF has discovered multiple cybersecurity vulnerabilities impacting hundreds of millions of Internet of Things (IoT) devices across a wide range of industries, including medtech. The risks from the security loopholes, dubbed Ripple20, are high and could allow hackers to take control of infusion pumps remotely and alter medication dosages, according to an example given by the lab.

The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency issued an advisory last week saying it was aware of Ripple20 and warned that "a remote attacker can exploit some of these vulnerabilities to take control of an affected system." CISA's advisory listed medtechs Baxter, B. Braun, and medical imaging company Carestream as being "affected" by the security loopholes. Medtronic and Philips appeared as "not affected" on the list.  

While Carestream was not immediately available for comment, Baxter and B. Braun each shared written statements with MedTech Dive calling the vulnerabilities low risk and manageable

The Ripple20 vulnerabilities identified by JSOF were discovered in code offered by Ohio-based third party software company Treck, which serves a large number of IoT device manufacturers. The issues stem specifically from Treck's software library, which has been widely disseminated.

"Affected vendors range from one-person boutique shops to Fortune 500 multinational corporations, including HP, Schneider Electric, Intel, Rockwell Automation, Caterpillar, Baxter, as well as many other major international vendors suspected of being of vulnerable in medical, transportation, industrial control, enterprise, energy (oil/gas), telecom, retail and commerce, and other industries," according to JSOF, a cybersecurity firm that says it caters to big corporations.

Nick Yuran, CEO of cybersecurity consultancy Harbor Labs in Baltimore, says his firm is actively following the Ripple20 vulnerabilities and issued a rare security alert to all of its clients, including infusion pump customers, urging them to inspect their systems and confirm whether they employ the Treck stack.

"In the most severe cases, an attacker may perform remote code execution, which gives the attacker complete control of the device," Yuran said. "We are advising our clients to take Ripple20 very seriously."

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Originally published by
Greg Slabodkin | June 24, 2020
MedTech Dive

 

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Bronze Level Contributor

Acute myeloid leukemia (AML) is a malignant clonal disease originating from myeloid hematopoietic stem/progenitor cells. It is a quickly progressing disease in which too many abnormal white blood cells are found in the bone marrow. AML is the second most common form of leukemia in children after acute lymphoblastic leukemia (ALL), and notoriously difficult to cure, due to its resistance to standard treatments.

Now, scientists at the Children’s Cancer Institute in Australia report they have discovered a new and improved way to treat the poor-prognosis acute myeloid leukemia. Their study, “Targeting RSPO3-LGR4 Signaling for Leukemia Stem Cell Eradication in Acute Myeloid Leukemia,” is published in Cancer Cell and led by Jenny Wang, PhD, senior lecturer and ARC future fellow at the Faculty of Medicine, UNSW Australia and a group leader of cancer and stem cell biology at Children’s Cancer Institute.

The scientists investigated what they believe is the culprit for AML, leukemia stem cells (LSCs).”Leukemia stem cells have their own protective mechanisms that make them resistant to anticancer drugs,” stated Wang.”After chemotherapy, if even one leukemic stem cell is left alive, it can regenerate and the disease can come back.” Stem cells are not only capable of giving rise to different types of cells, but also of cloning themselves indefinitely in a process known as self-renewal.

Scientists attempted a new treatment approach by targeting the leukemia stem cells and disrupting the self-renewal process. Using a mice model with growing cancer cells taken directly from patients with AML, the scientists used an antibody treatment to disrupt the interaction of two molecules, RSPO2/3 and RSPO-LGR4. RSPO-LGR4 upregulates key self-renewal genes and is essential for LSC self-renewal in a subset of AML. RSPO2/3 serves as stem cell growth factors to block differentiation and promote proliferation of primary AML patient blasts.

“Blocking the RSPO3-LGR4 interaction by clinical-grade anti-RSPO3 antibody (OMP-131R10/rosmantuzumab) impairs self-renewal and induces differentiation in AML patient-derived xenografts but does not affect normal hematopoietic stem cells, providing a therapeutic opportunity for HOXA9-dependent leukemia,” the researchers wrote.

The scientists discovered that the antibody reduced the amount of leukemia, and prevented new leukemia cells from growing. The antibody treatment also did not harm healthy stem cells, which children treated for AML require to reconstitute their blood system after treatment.

Scientists are optimistic in the therapy progressing to clinical trials and hope it will prove to be an effective therapy in children with AML.

Originally published by
GEN - Genetic Engineering & Biotechnology News
June 22, 2020

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Bronze Level Contributor

Lunit’s Insight CXR program is designed to scan thoracic X-rays and spot the signs of different conditions and infections, such as tuberculosis, as well as fibrosis, pneumothorax and the existence of potentially cancerous lung nodules. (Lunit)

GE Healthcare launched an artificial intelligence-powered chest X-ray analysis suite, designed to spot and highlight eight common conditions, using algorithms built by the South Korean startup Lunit. 

Lunit’s Insight CXR program is designed to scan thoracic X-rays and label the probable signs of diseases such as tuberculosis and pneumonia, including that linked to COVID-19, as well as fibrosis, pneumothorax and the existence of potentially cancerous lung nodules.

“The launch of our Thoracic Care Suite is a part of GE Healthcare’s larger effort to help ensure clinicians and partners on the front lines have the equipment they need to quickly diagnose and effectively treat COVID-19 patients,” GE Healthcare President and CEO Kieran Murphy said in a statement. “The pandemic has proven that data, analytics, AI and connectivity will only become more central to delivering care.”

The AI overlays its results on top of the X-ray image, outlining the location of an abnormality along with a score that estimates the probability of the finding. The software also generates case reports summarizing each evaluation. Lunit’s algorithms previously received a CE Mark in November 2019, and have been used clinically in Korea, China, Thailand, Mexico and the United Arab Emirates.

GE Healthcare estimates that over 1.4 billion chest X-rays are performed worldwide every year—a workload that threatened to overwhelm radiologists, even before the onset of COVID-19 and the pandemic’s over 8 million confirmed cases, with many needing to undergo scans for pneumonia and acute respiratory distress. 

“To have our AI made available with a market-leading vendor like GE Healthcare—especially as part of the Thoracic Care Suite—is a significant advancement in delivering solutions to various customers within GE Healthcare’s install base and bringing us all one step closer to embracing AI as a part of today’s standard of care,” said Lunit CEO Brandon Suh. The two companies described the collaboration as one of the first of its kind to merge commercially available AI products to an existing X-ray manufacturer.

The software package is available for GE Healthcare’s fixed and mobile X-ray and fluoroscopy hardware, and can be deployed without taking on an additional enterprise IT project, the company said. The suite also scans for atelectasis, calcification, cardiomegaly, mediastinal widening and pleural effusions.

In studies, the system demonstrated a 97% to 99% accuracy rate, and showed that it could reduce the amount of reading time per case for radiologists by one-third.

Originally published by
Conor Hale - June 19, 2020
Fierce Biotech

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Bronze Level Contributor

Researcher Anna Honko prepares the assay in the BSL-4 in the National Emerging Infectious Diseases Laboratories (NEIDL). [Courtesy of the Griffiths lab at Boston University's National Emerging Infectious Diseases Laboratories (NEIDL)]

Researchers at the University of California, San Diego (UCSD) have developed “nanosponges” that can attract and neutralize SARS-CoV-2 in cell culture, causing the virus to lose its ability to hijack host cells and reproduce. Cloaked in the cell membranes from either human lung cells or human immune cells, the nanoparticles are designed to protect the healthy cells that the virus invades, rather than targeting the virus itself. The approach effectively uses nanoparticles to soak up harmful pathogens and toxins, hence the name nanosponges.

When tested by researchers at Boston University, both the lung cell and immune cell types of nanosponge caused the SARS-CoV-2 virus to lose nearly 90% of its viral infectivity in a dose-dependent manner. Viral infectivity is a measure of the ability of the virus to enter the host cell and exploit its resources to replicate and produce additional infectious viral particles. “Traditionally, drug developers for infectious diseases dive deep on the details of the pathogen in order to find druggable targets,” said Liangfang Zhang, PhD, a nanoengineering professor at the UCSD Jacobs School of Engineering. “Our approach is different. We only need to know what the target cells are. And then we aim to protect the targets by creating biomimetic decoys.”

Zhang and colleagues reported on their technology in Nano Letters, in a paper titled, “Cellular Nanosponges Inhibit SARS-CoV-2 Infectivity.

Scientists searching for new antiviral drugs need to understand the molecular mechanisms of viral infection, but this is a particular challenge with emerging viruses such as SARS-CoV-2, the authors noted. Moreover, antiviral medicines often target a single viral species, and so aren’t applicable to other viral species or families, and they may also become ineffective as the target virus mutates. “Therefore, an effective therapeutic agent to inhibit SARS-CoV-2 infectivity, as well as its potential mutated species, would be a significant game-changer in the battle against this public health crisis,” they continued.

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Originally published by
GEN Genetic Engineering & Biotechnology News | June 18, 2020

 

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Gold Level Contributor

Photo credit: pongschole1, Getty Images

MedRhythms, a digital health startup using sensors and music for post-stroke walking rehabilitation, received an FDA Breakthrough Device Designation.

After seeing music help his patients, Brian Harris, a board-certified music therapist, turned his work into a digital therapeutic. Called MedRhythms, the Portland-based startup uses music in conjunction with sensors to help chronic stroke patients improve their walking.

The company made an important step toward bringing its first product to market: It received the FDA’s Breakthrough Device Designation, which can accelerate the regulatory process for medical devices. To qualify, companies must prove that no alternative exists and that it addresses a significant unmet need.

“There is currently no standard of care for chronic stroke survivors with walking deficits, yet these impairments are strongly linked to fall risk, lack of independence, and decreased quality of life. We are thrilled the FDA has designated our product as a Breakthrough Device, recognizing its potential to impact an area of high unmet need and bringing us one step closer to reaching people who need this care,” Harris, CEO and co-founder of MedRhythms, said in a news release.

Danielle Briggeman, the company’s clinical and regulatory affairs manager, said she was hopeful that the designation would allow MedRhythms to bring its first product to market with an expedited timeline.

“Having this designation opens the door for swift, interactive discussions with FDA on our development efforts that we otherwise would not have under the current Pre-Submission Program,” she said in a news release.

MedRhythms developed sensors that patients can attach to their shoes. After calculating their current stride, the system begins playing music through headphones. It can change the tempo of the music so they can improve the speed of their walking.

MedRhythms is testing the system in a randomized clinical trial between five rehabilitation hospitals and research centers, including the Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey, Mt. Sinai Hospital in New York, Spaulding Rehabilitation Hospital in Boston, and the Boston University Neuromotor Recovery Laboratory. It will evaluate the system’s impact on walking among stroke survivors with post-stroke walking impairments.

In the future, MedRhythms plans to develop additional products for Parkinson’s disease, multiple sclerosis, aging and fall prevention.

Initially published by
Elise Reuter | June 15, 2020
MedCityNews

 

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Gold Level Contributor

Medtronic received a CE mark for its advanced hybrid closed loop system dubbed the MiniMed 780G with the ability to deliver automatic boluses of insulin in addition to maintaining background levels. (Medtronic)

 

A new version of Medtronic’s advanced, hybrid closed-loop insulin delivery system showed it could help improve blood sugar control throughout the day in adolescents and young adults with Type 1 diabetes.

The clinical study compared the next-generation system to the medtech giant’s mainstay connected insulin pump, the MiniMed 670G, designed to adjust background insulin levels every five minutes based on readings from a continuous glucose monitor.

In this trial, the newer system employed the same 670G hardware but incorporated an upgraded “fuzzy logic” algorithm aimed at reducing the number of high blood sugar events while also avoiding drops to low blood sugar levels.

Among participants aged 14 to 29, the system increased the amount of time spent in a healthy glucose range by 10 percentage points, up to about 16 hours across a 24-hour period.  

At the same time, the advanced system had a larger number of individuals reaching a time-in-range target of 70%, up threefold compared to baseline, versus the previous 670G’s twofold increase.

Sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, the study and its results were presented virtually at the annual scientific sessions of the American Diabetes Association (ADA).

“This age group has traditionally been the most difficult group in which to optimize glucose management and the FLAIR study shows that individuals using any type of therapy, even insulin injections without a pump or CGM system, can benefit from the next generation [advanced, hybrid closed loop automated insulin delivery] therapy,” said the study’s co-primary investigator, Richard Bergenstal, executive director of the International Diabetes Center at HealthPartners.

“There is much interest in the future of advanced technology to treat Type 1 diabetes and the AHCL system is a significant step forward for adolescents or young adults who have a hard time managing their glucose levels,” added Bergenstal, who previously served as the ADA’s president of medicine and science.

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Originally published by
Conor Hale | Jun 15, 2020
FierceBiotech

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Bronze Level Contributor

The novel coronavirus pandemic has hit healthcare specialties hard, but some fared better than others. (Pixabay)

Healthcare revenue fell by nearly 50% in March and April for specialties that include primary care, oral surgery, dermatology and cardiology, a new study found.

The study, published (PDF) Wednesday by FAIR Health, which estimates healthcare costs and runs a claims database, details the drop in healthcare utilization for non-hospital providers. The industry has struggled financially with the cancellation of elective procedures and hesitancy from patients to go to the doctor’s office.

Nationally, from March 2019 to March 2020, the use of professional services decreased by 65% and revenue dropped by 45%. From April 2019 to April 2020, the drop in utilization increased to 68% and revenue loss to 48%.

Fair Health’s study also examined which providers took the biggest financial hits.

The northeastern region of the U.S. saw the greatest decline in healthcare utilization with a 60% drop and a revenue loss of 55%.

In April, that utilization fell even further by 80% compared with April 2019, and there was a 79% drop in revenue. The Northeast has been hit hard by the coronavirus in April and March, with New York and several other cities becoming hot spots.

FAIR Health also explores which specialties had the largest decreases in utilization at the onset of the pandemic.

Oral surgery had the biggest drop in utilization in March 2020 with a decline of 80% compared to 2019. Gastroenterology was the second-largest decline with a 73% drop in March and a 77% decline in April.

Cardiology and dermatology specialties also had a major dip of 62% in utilization in March 2020.

“A survey of dermatologists in March 2020 found that 66.3 percent of respondents estimated a greater than 50 percent decrease in patient volume in the coming two weeks,” the study found.

Orthopedics had a similar drop of 58% in healthcare utilization in March and 65% in April compared to similar periods in 2019.

But pediatric primary care physicians had the smallest drop in utilization, with 52% in March, and had a 32% decline in revenue.

“There was little change from March-April 2019 to March-April 2020 in preventive care visits for pediatric patients 0-4 years of age, whether from the standpoint of utilization or of revenue-based on total estimated allowed amounts,” the study said.

Evaluation and management visits became more common relative to other procedures in part because many of these services can be rendered by telehealth, which has exploded in use during the pandemic.

The study was based on an analysis of private insurance claims from FAIR Health’s database.

While healthcare utilization has dropped in March and April, health systems and physician offices have sought to reopen procedures.

Originally published by
Robert King | Jun 11, 2020
Fierce Healthcare

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Gold Level Contributor

A study of 600 health professionals involving a smartphone app, AI-driven model, and wearable tech shows encouraging results in predicting COVID-19 symptoms three days in advance. (WVU Rockefeller Neuroscience Institute)

One of the most daunting aspects of fighting the pandemic is that asymptomatic people can spread the virus without knowing they are infected.

Early results of the first phase of a study by the West Virginia University Rockefeller Neuroscience Institute (RNI) and WVU Medicine, using Oura Ring sensor data and AI models, show that COVID-19 related symptoms can be detected up to three days before they show up. Additionally, the team is gaining a greater understanding of the recovery and treatment of COVID-19.

“The holistic and integrated neuroscience platform developed by the RNI continuously monitors the human operating system, which allows for the accurate prediction of the onset of viral infection symptoms associated with COVID-19,” said Ali Rezai, M.D., executive chair of the WVU Rockefeller Neuroscience Institute. “We feel this platform will be integral to protecting our healthcare workers, first responders, and communities as we adjust to life in the COVID-19 era.

The RNI platform uses a smartphone app, the Oura Ring, and AI-guided models to forecast and predict the onset of COVID-19 related symptoms such as fever, coughing, and breathing difficulties three days in advance with over 90 percent accuracy. This technology can potentially serve as a critical decision-making tool to help contain the spread of the virus, safely re-open communities, strengthen the economy, and facilitate public health containment strategies.

A key part of the study is the Oura Ring by the wearable health tech company Oura Health. Designed to be worn on a finger, the Oura Ring captures body measurements like heart rate, HRV, temperature and sleep. The novel device features infrared LEDs, NTC temperature sensors, an accelerometer, and a gyroscope.

The study to determine if an AI-driven model could be developed to detect symptoms in advance involved the monitoring of 600 healthcare professionals. The study integrated physiologic measures with psychological, cognitive, and behavioral biometrics, including stress and anxiety, to track the mind-body connection in the context of asymptomatic infection.

The RNI will be expanding the study to more than 10,000 participants through national partners including Thomas Jefferson University in Philadelphia, Vanderbilt University in Nashville, and other academic institutions in West Virginia, New York City, and California.

“We are hopeful that Oura’s technology will advance how people identify and understand our body’s most nuanced physiological signals and warning signs, as they relate to infectious diseases like COVID-19,” Harpreet Rai, CEO of Oura Health, said. “Partnering with the Rockefeller Neuroscience Institute on this important study helps fulfill Oura’s vision of offering data for the public good and empowering individuals with the personal insights needed to lead healthier lives.”  

In addition to the platform’s ability to detect symptoms in advance, the research team is now launching the next phase of its study, which will show the location of reported symptoms. The RNI app is now available to the general public. People interested in participating in the study should visit RNI’s  COVID19 webpage.

The Oura ring is also being used in other COVID-19 studies, as reported earlier in FierceElectronics.

Originally published by
Karen Field | Jun 10, 2020
Fierce Electronics

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Gold Level Contributor

Certain non-National Institute for Occupational Safety and Health-approved respirators manufactured in China are still authorized for one-time or disposable use, the FDA said. (iStock)

The FDA has revised its previous emergency authorizations for reprocessing N95 respirators, saying certain masks imported from China may not be able to withstand the decontamination process.  

The agency said it received new information on the effective reuse of different models from researchers under the Centers of Disease Control and Prevention (CDC).

More broadly, the FDA is no longer allowing the decontamination of any respirators featuring exhalation valves, and decontamination systems are only authorized by the agency to reprocess non-cellulose compatible N95 masks.

The move comes one month after the FDA revoked emergency authorizations granted to more than 50 China-based manufacturers of face masks that had not been tested and approved by the CDC’s National Institute for Occupational Safety and Health, or NIOSH. The personal protective equipment had been imported to help meet severe shortages, but the policy was reversed in early May after certain masks were found to be less than effective. 

It also comes just days after federal prosecutors charged one Chinese company with selling nearly 500,000 inferior masks to U.S. healthcare workers, falsely labeled as NIOSH-approved N95 respirators, according to a report from The Wall Street Journal.

Certain non-NIOSH-approved respirators made in China are still authorized for one-time or disposable use, the FDA said. The CDC recommends that any decontaminated respirator only be used when new, approved masks are unavailable and that masks with a poor fit or visible damage should not be used. 

“We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health,” said Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs, in an agency statement. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected.”

Currently, the FDA’s list of N95 respirators authorized for decontamination and reuse include four models manufactured by 3M—when made in Japan, South Korea, Singapore, Turkey or the U.K.—as well as Dromex’s mask model manufactured in South Africa.

Originally posted by
Conor Hale | Jun 8, 2020
FierceBiotech

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Gold Level Contributor

Dive Brief:

 

  • Three months after pausing its roughly 240-patient pivotal study of forthcoming Horizon automated insulin delivery due to a software anomaly, Insulet said Friday it has resumed the trial, reaffirming its later than originally expected U.S. launch target for the first half of 2021.
  • Horizon, a smartphone-controlled, CGM-integrated automated insulin delivery system, will most immediately compete with offerings from Tandem Diabetes, namely its Control-IQ system, the first interoperable automated glycemic controller allowed by FDA. Horizon is slated to be integrated with devices from both leading horses in the CGM market, Abbott and Dexcom, and analysts at Cowen believe the system to be "the most important catalyst" for Insulet's business and stock.
  • Insulet's study began at the end of 2019 and, prior to the 3-month delay, was targeting completion in July. At the time it was paused, 9,000 patient days on the system had been completed with about 12,000 to go, analysts at Stifel outlined in a note to investors Friday, projecting Insulet needs about 50 more trial days per patient, indicating an August 2020 wrap-up for the study. Analysts at Cowen, on the other hand, said the remainder of the trial shouldn't take more than three to five months, taking into account "extra logistics associated with virtual patient follow ups" and site training on new procedures.

Dive Insight:

 

Unlike many medtechs who've dealt with key clinical trial disruptions in 2020, Insulet's issue stemmed not from the effects of COVID-19 but from a software anomaly identified in March. At the time, the company described the issue as "rare," but acknowledged it could result in incorrect insulin dosing, which may lead to dangerous hypo- or hyperglycemia, thus necessitating immediate attention.

Competitor Tandem dealt with a similar issue during its own pivotal trial of the now FDA-authorized Control-IQ technology. By comparison, FDA's review of the Tandem system prior to authorization took about five months.

"FDA review timelines remain in flux, but the 1H21 timeline seems very reasonable," analysts at Stifel wrote in a note to investors on Friday. "We continue to believe Horizon will be a highly impactful new closed loop insulin system, likely driving both new-to-pumping patients and competitive switches."

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Originally published by
Maria Rachal | June 5, 2020
MEDTECHDIVE

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Bronze Level Contributor
“NICE” ink developed by Texas A&M researchers can be used to 3D print customizable craniofacial implants.

Courtesy of Akhilesh Gaharwar
 
The material for craniofacial bone grafts can facilitate cell regrowth and be tailored to an individual's face and skull structure.
 

Subtle variations in the architecture of the 22 bones of the skull give each one of us a unique facial profile. So repairing the shape of skull defects, in the event of a fracture or a congenital deformity, calls for a technique that can be tailored to an individual’s face or head structure.

In a new study, researchers at Texas A&M University have combined 3D printing, biomaterial engineering and stem cell biology to create superior, personalized bone grafts. When implanted at the site of repair, the researchers said these grafts will not only facilitate bone cells to regrow vigorously, but also serve as a sturdy platform for bone regeneration in a desired, custom shape.

“Materials used for craniofacial bone implants are either biologically inactive and extremely hard, like titanium, or biologically active and too soft, like biopolymers,” said Roland Kaunas, associate professor in the Department of Biomedical Engineering. “In our study, we have developed a synthetic polymer that is both bioactive and mechanically strong. These materials are also 3D printable, allowing custom-shaped craniofacial implants to be made that are both aesthetically pleasing and functional.”

A detailed report on the findings was published online in the journal  Advanced Healthcare Materials in March.

Each year, about 200,000 injuries occur to bones of the jaw, face and head. For repair, physicians often hold these broken bones in place using titanium plates and screws so that surrounding bone cells can grow and form a cover around the metal implant. Despite its overall success in aiding bone repair, one of the major drawbacks of titanium is that it does not always integrate into bone tissue, which can then cause the implant to fail, requiring another surgery in advanced cases.

Thus, biocompatible polymers, particularly a type called hydrogels, offer a preferable alternative to metal implants. These squishy materials can be loaded with bone stems cells and then 3D printed to any desired shape. Also, unlike titanium plates, the body can degrade hydrogels over time. However, hydrogels also have a known weakness.

“Although the pliability of hydrogel-based materials makes them good inks for 3D bioprinting, their softness compromises the mechanical integrity of the implant and the accuracy of printed parts,” said Akhilesh Gaharwar, associate professor in the Department of Biomedical Engineering.

To increase the stiffness of the hydrogel, the researchers developed a nanoengineered ionic-covalent entanglement or “NICE” recipe containing just three main ingredients: an extract from seaweed called kappa carrageenan, gelatin and nanosilicate particles that both stimulate bone growth and mechanically reinforce the NICE hydrogel.

First, they uniformly mixed the gelatin and kappa carrageenan at microscopic scales and then added the nanosilicates. Gaharwar said the chemical bonds between these three items created a much stiffer hydrogel for 3D bioprinting — with an almost eight-fold increase in strength compared to individual components of NICE bioink.

Next, they added adult stem cells to 3D parts printed with NICE ink and then chemically induced the stem cells to convert into bone cells. Within a couple of weeks, the researchers found that the cells had grown in numbers, producing high levels of bone-associated proteins, minerals and other molecules. In aggregate, these cell secretions formed a scaffold, known as an extracellular matrix, with a unique composition of biological materials needed for the growth and survival of developing bone cells.

When the scaffolds are fully developed, the researchers noted that the bone cells could be removed from the scaffold and the hydrogel-based implant can then be inserted into the site of skull injury where the surrounding, healthy bones initiate healing. Over time, the 3D printed scaffolds biodegrade, leaving behind a healed bone in the right shape.

“The idea is to have the body’s own bone repair machinery participate in the repair process,” Kaunas said. “Our biomaterial is enriched with this regenerative extracellular matrix, providing a fertile environment to naturally trigger bone and tissue restoration.”

The researchers said that the 3D-printed scaffolds provide a strong structural framework that facilitates the attachment and growth of healthy bone cells. Also, they found that developing bone cells penetrate through the synthetic material, thereby increasing the functionality of the implant.

“Although our current work is focused on repairing skull bones, in the near future, we would like to expand this technology for not just craniomaxillofacial defects but also bone regeneration in cases of spinal fusions and other injuries,” Kaunas said.

Other contributors to this study include Candice Sears, Eli Mondragon, Zachary Richards, Nick Sears and David Chimene from the Texas A&M Department of Biomedical Engineering; and Eoin McNeill and Carl A. Gregory from the Texas A&M Health Science Center.

This research is funded by the National Institutes of Health and the National Science Foundation.

Originally published by
By Vandana Suresh, Texas A&M University College of Engineering | JUNE 2, 2020
Texas A&M - Original Source

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The microfluidic device Abhishek Jain and his team developed to help detect blood clots.

Texas A&M College of Engineering

Researchers in the Department of Biomedical Engineering at Texas A&M University are working on a new way to detect blood clots, especially in pediatric patients.

Unlike what a biology textbook may show, blood vessels are not straight cylinders. They are tortuous, meaning they have complex curves, spirals and bends. When the blood reaches these curves, it makes changes to its fluid mechanics and interactions with the vessel wall. In a healthy person, these changes are in harmony with the tortuous microenvironment, but when diseased, these environments could lead to very complex flow conditions that activate proteins and cells that eventually lead to blood clots.

Assistant Professor Abhishek Jain said a large challenge in medicine is that the medical devices used to detect clots and assess anti-blood clotting drug effects are entirely chemistry-based.

“They do not incorporate the flow through the naturally turning and twisting blood vessels, which are physical regulators of blood clotting,” Jain said. “Therefore, the readouts from these current static systems are not highly predictive, and often result in false positives or false negatives.”

To approach the problem from a new angle, researchers in Jain’s lab at Texas A&M designed a microdevice that mimics tortuous blood vessels and created a diseased microenvironment in which blood may rapidly clot under flow. They showed this biomimetic blood clotting device could be used to design and monitor drugs that are given to patients who suffer from clotting disorders.

Jain said he can see several applications for the device, including critical care units and military trauma care units.

“It can be used in detection of clotting disorders and used in precision medicine where you would want to monitor pro-thrombotic or anti-thrombotic therapies and optimize the therapeutic approach,” Jain said.

After developing the device, the team took it into the field for a pilot study. Working with Dr. Jun Teruya, chief of transfusion medicine at Texas Children’s Hospital and Baylor College of Medicine, the team coordinated with clinicians to test the device with pediatric patients in critical care whose heart and lungs were not working properly.

These patients were in need of an extracorporeal membrane oxygenation (ECMO) machine, which provides cardiac and respiratory support in exchange of oxygen and carbon dioxide.

A common complication in ECMO is blood clotting, so patients are administered anticoagulants to prevent clotting. However, ECMO machines are also known to “eat” clotting proteins and platelets, which puts anticoagulated patients in further risk of bleeding. Anticoagulated pediatric patients on ECMO are especially prone to bleeding.

Current chemically based blood clotting tests are expensive, time-consuming, can be unreliable and require a skilled technician. Jain’s team’s tortuosity based microfluidic system doesn’t require expensive chemicals, is quick, with results within 10-15 minutes, uses low blood sample volume and is easy to operate.

“The margin for error is essentially zero for these patients,” Jain said. “Therefore, it’s imperative that all the tests, not just clotting tests, must work and provide clinicians with quick and reliable information about their patient so they can provide the best care possible.”

By having the opportunity to test their system with real patients, Jain said his team was able to demonstrate that their design could detect bleeding in anticoagulated patients with low platelet counts, which can help guide doctors to make better evidence-based clinical decisions for their patients.

The study was recently published in Nature’s Scientific Reports journal.

For Jain and his team, the next stage is continued clinical studies to compare their approach to standard methods and hopefully demonstrate key performance advantages.

This project was funded by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health, the Texas A&M Engineering Experiment Station and Baylor College of Medicine.

Originally published by
Jennifer Reiley, Texas A&M University College of Engineering | MAY 19, 2020

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Flickr; Phalinn Ooi

Dive Brief:

  • A Bayesian reanalysis of five-year clinical trial data found coronary artery bypass surgery, also referred to as CABG, yields better results in left main coronary artery disease patients than Abbott’s Xience stent, going against the controversial conclusion of the original analysis. Findings from the reanalysis were published in JAMA Internal Medicine on Monday,.

  • With the reanalysis putting the probability of more deaths in the Xience arm at 99%, a Cedars-Sinai Medical Center cardiologist used the study to call for revascularization guidelines to stop recommending PCI for low-complexity left main patients.​​

  • Abbott, which funded the original study, did not have an immediate comment regarding the reanalysis of the Evaluation of Xience versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial data.

Dive Insight:

Release of five-year data from the Abbott-funded EXCEL clinical trial in the New England Journal of Medicine last November could have been the moment that a long-running debate about the merits of PCI and CABG was put to rest. Instead, the presentation further fanned the flames, most explosively when the former chairman of the study’s surgical committee argued its conclusions were at “complete odds” with the data. The surgeon, David Taggart, withdrew his name from the paper over the dispute.

The controversy centered on the claim that Xience was noninferior to CABG in terms of the risk of death and major cardiovascular events. As Taggart saw it, the data showed “a strong benefit” in favor of CABG over PCI that the conclusions of the study failed to reflect.

In response to the controversy, James Brophy of McGill University Health Center reanalyzed the data. Brophy’s conclusions are more in line with Taggart’s position than the findings of the original paper. 

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Originally published by
Nick Paul Taylor | June 3, 2020
Medtech Dive


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Brian Tucker / MedTech Dive - With assets via Getty Images

Neuronetics, TransEnterix and CVRx are all seeking to maintain operations and win new customers at a time when procedures and sales are disrupted and supplies to help resume them are hard to come by.

Dan Guthrie was working as an expat managing sales for a pharmaceutical company in Singapore when the SARS outbreak took place.

So as COVID-19 began to spread more widely, “I probably, admittedly, had a little bit of hubris and thought ‘hey, I’m maybe better prepared than most.' But certainly this crisis has far eclipsed what I dealt with back then,” said Guthrie, who now serves as chief commercial officer at Neuronetics, which specializes in transcranial magnetic stimulation.

Delivered in a physician’s office, TMS is a neuromodulation-based treatment regimen to target depression and other chronic psychiatric and neurological disorders. Despite an arguably heightened need for mental health supports during the pandemic, procedures with Neuronetics’ device were largely sidelined beginning in late March as providers shut down and patients grew uncomfortable with leaving home to seek care.

The Malvern, Pennsylvania-based company is among smaller medtechs working through financial challenges, exacerbated by sudden declines in product use and purchasing, and those related to rebooting business now that most of the U.S. is easing barriers to resuming elective care.

In early April, Neuronetics announced a plan to save cash and cut its staff by about 45%, or 96 employees. Capital equipment sales haven’t come to a total halt, but system placements have “no doubt” declined since the onset of COVID-19, Guthrie said in a recent interview with MedTech Dive.

Neuronetics went public in 2018 with a target price of $17; it now trades at below $2 with a market cap of approximately $34 million.

It received a $6.4 million loan from the congressional bailout Paycheck Protection Program earlier this year. It ultimately opted to repay the loan following press scrutiny of some public companies receiving support before independent firms, including call-outs of Neuronetics in Philadelphia news outlets.

One effort that’s helped as patients and providers seek a return to more normal care routines: sourcing and providing personal protective equipment to the practices using Neuronetics’ systems. Guthrie said the company counts the service as part of its cost of operating machinery.

But for a company like Neuronetics whose treatment doesn’t typically necessitate the use of PPE, it’s been a bit challenging to acquire the highly sought after equipment and quickly develop appropriate guidelines for use for providers. Guthrie, whose resume includes time at Zimmer Biomet and Medtronic, said he and colleagues who have worked in the medtech industry for quite some time were able to leverage relationships to find suppliers.

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Originally published by
Maria Rachal | June 1, 2020
Medtech Dive

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Bronze Level Contributor

A team led by Lawrence Livermore National Laboratory computer scientist Jay Thiagarajan has developed a new approach for improving the reliability of artificial intelligence and deep learning-based models used for critical applications, such as health care. Thiagarajan recently applied the method to study chest X-ray images of patients diagnosed with COVID-19, arising due to the novel SARS-Cov-2 coronavirus. This series of images depicts the progression of a patient diagnosed with COVID-19, emulated using the team’s calibration-driven introspection technique. Credit: Lawrence Livermore National Laboratory

As artificial intelligence (AI) becomes increasingly used for critical applications such as diagnosing and treating diseases, predictions and results regarding medical care that practitioners and patients can trust will require more reliable deep learning models.

In a recent preprint (available through Cornell University's open access website arXiv), a team led by a Lawrence Livermore National Laboratory (LLNL) computer scientist proposes a novel deep learning approach aimed at improving the reliability of classifier models designed for predicting disease types from diagnostic images, with an additional goal of enabling interpretability by a medical expert without sacrificing accuracy. The approach uses a concept called confidence calibration, which systematically adjusts the model's predictions to match the human expert's expectations in the real world.

"Reliability is an important yardstick as AI becomes more commonly used in high-risk applications, where there are real adverse consequences when something goes wrong," explained lead author and LLNL computational scientist Jay Thiagarajan. "You need a systematic indication of how reliable the model can be in the real setting it will be applied in. If something as simple as changing the diversity of the population can break your system, you need to know that, rather than deploy it and then find out."

In practice, quantifying the reliability of machine-learned models is challenging, so the researchers introduced the "reliability plot," which includes experts in the inference loop to reveal the trade-off between model autonomy and accuracy. By allowing a model to defer from making predictions when its confidence is low, it enables a holistic evaluation of how reliable the model is, Thiagarajan explained.

In the paper, the researchers considered dermoscopy images of lesions used for skin cancer screening—each image associated with a specific disease state: melanoma, melanocytic nevus, basal cell carcinoma, actinic keratosis, benign keratosis, dermatofibroma and vascular lesions. Using conventional metrics and reliability plots, the researchers showed that calibration-driven learning produces more accurate and reliable detectors when compared to existing deep learning solutions. They achieved 80 percent accuracy on this challenging benchmark, in contrast to 74 percent by standard neural networks.

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Originally published by
Jeremy Thomas, Lawrence Livermore National Laboratory | June 1, 2020
TechXplore

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Bronze Level Contributor

sudok1/iStock

Neurodegenerative diseases can now potentially be detected up to 24 years ahead of time.

Researchers from University College London (UCL) in the U.K. have found a new method of detecting neurodegenerative diseases, such as Alzheimer's and Huntington's, up to 24 years in advance.

Their findings could hugely help in clinical trials by finding the almost-precise timing to begin treating the diseases. 

Their findings were published in the Lancet Neurology.

No treatment

There is currently no treatment for many neurodegenerative illnesses, so finding a way to treat people before the genetic mutation causes functional impairments has been on scientists' minds. 

"Ultimately, our goal is to deliver the right drug at the right time to effectively treat this disease – ideally we would like to delay or prevent neurodegeneration while function is still intact, giving gene carriers many more years of life without impairment," explained Professor Sarah Tabrizi of UCL and study lead

Tabrizi continued "As the field makes great strides with the drug development, these findings provide vital new insights informing the best time to initiate treatments in the future, and represent a significant advance in our understanding of early Huntington’s."

The study focused on Huntington's mutation carriers, examining a cohort much younger than has previously ever been studied. It was also the most extensive study of the illness ever carried out.

The team discovered that there were no changes in thinking, behavior, or involuntary movements commonly found in the disease when they examined the volunteers who were carriers of Huntington's. However, the team did note a small increase in the spinal fluid of a neuronal protein called neurofilament light (NfL), which can lead to nerve cell damage. 

Co-first author of the study, Dr. Paul Zeun said, "We have found what could be the earliest Huntington’s-related changes, in a measure which could be used to monitor and gauge effectiveness of future treatments in gene carriers without symptoms."

First co-author of the study, Dr. Rachael Scahill explained "We suspect that initiating treatment even earlier, just before any changes begin in the brain, could be ideal, but there may be a complex trade-off between the benefits of slowing the disease at that point and any negative effects of long-term treatment."

The team's findings could have a huge effect on people suffering, or going to suffer, from such neurodegenerative illnesses

Originally published by
Fabienne Lang
June 1, 2020
Interesting Engineering

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