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Gold Level Contributor

Finding follows discovery by TAU researchers of Alzheimer's-like traits in brain of autistic child

An extensive international study led by Prof. Illana Gozes of Tel Aviv University's Department of Human Molecular Genetics and Biochemistry found deposits of the tau protein typically found in Alzheimer's patients in tissues taken from the postmortem brain of a 7-year-old autistic child.

The child suffered from the ADNP syndrome, a mutation that causes a deficiency/malfunctioning of the ADNP protein essential for brain development. In light of these findings, the researchers tested an experimental drug called NAP, originally developed for Alzheimer's disease, on nerve cells in a model of ADNP syndrome with the mutation that induced Alzheimer's-like symptoms. The experiment was a success, with the damaged nerve–like cells returning to normal function.

The study was conducted in close collaboration with researchers from TAU's Blavatnik School of Computer Science, Sheba Medical Center, and a variety of research institutions across Europe, including the biotechnology institute BIOCEV in the Czech Republic, the Aristotle University of Thessaloniki in Greece, the University of Antwerp in Belgium, and the University Hospital Centre in Zagreb, Croatia. The study was published on July 13 in the journal Translational Psychiatry.

Prof. Gozes explains that the current study is based on tissues taken from the brain of a 7-year-old boy with ADNP syndrome who died in Croatia. "When we compared the postmortem ADNP syndrome brain tissues to tissue from the brain of a young person without ADNP syndrome, we found deposits of the tau protein in the ADNP child, a pathology that characterizes Alzheimer's disease," Prof. Gozes says.

The researchers then "treated" damaged nerve-like cells carrying an ADNP mutation similar to the deceased child's mutation with a drug candidate called NAP. NAP was developed in Prof. Gozes's laboratory and was originally intended to be used to help treat Alzheimer's disease. "NAP is actually a short active fragment of the normal ADNP protein,” says Prof. Gozes. "When we added NAP to the nerve cells carrying an ADNP mutation, the tau protein bound to the nerve cell skeleton properly, and the cells returned to normal function.

"The fact that NAP treatment has been successful in restoring the normal function of neuronal-like cell models with impaired ADNP raises hopes that it may be used as a remedy for ADNP syndrome and its severe implications, including autism," Prof. Gozes continues. "Moreover, because other genetic disorders related to autism are characterized by tau pathologies in the brain, we hope that those suffering from these syndromes will also be able to benefit from NAP treatment in the future."

NAP (also called CP201) has been classified as an "orphan drug" by the US Food and Drug Administration and is currently in the preparatory stages of a clinical trial in children with ADNP syndrome through the company Coronis Neurosciences.

In another phase of the study, the researchers sought to broaden their understanding of the effects of the mutation that causes ADNP syndrome. To do this, they extracted the genetic material mRNA (messenger RNA) from the tissues of the deceased child and performed an expression analysis of about 40 proteins in the same child, encoded by the mRNA. Full genetic sequencing was also performed to determine protein expression in white blood cells taken from three other children with ADNP syndrome.

An in-depth study was carried out on all of the data obtained in the genetic sequencing using advanced bioinformatics computational tools. The data were compared to online databases of protein expression data from healthy individuals, revealing a variety of characteristics that were common to the children with the syndrome but very different from the normal appearance of these proteins.

Prof. Gozes concludes that "the significance of these findings is that the mutation that causes ADNP syndrome damages a wide range of essential proteins, some of which bind to the tau protein, among other things, and impair its function as well. This creates various pathological effects in the brains and other tissues of children with ADNP syndrome, one of which is the formation of tau deposits, known to be a characteristic of Alzheimer's disease.

"The vast and in-depth knowledge we have accumulated through the present study opens the door to further extensive and diverse research. We hope and believe that we will ultimately reach the goal of developing a drug or drugs that will help children with autism resulting from genetic mutations."

The research paper is available at the journal's web site here.

Originally published by
Tel Aviv University | July 28, 2020

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Bronze Level Contributor

The app allows a person's Apple smartphone to take the place of a separate programmer device, and also supports video chats with healthcare providers. (Photo: Abbott)

The FDA approved a new smartphone app from Abbott allowing people to personalize their own neuromodulation therapies, including regimens for chronic pain and movement disorders such as Parkinson’s disease.

Compatible with Apple products, the devicemaker’s NeuroSphere Digital Care platform and its newly approved patient controller app are also designed to encourage more virtual connections with healthcare providers, and allow interactions to take place remotely in the face of the COVID-19 pandemic.

This includes supporting video chat conversations with care teams to guide changes. And by downloading the app, a person’s personal smartphone can eliminate the need for maintaining a separate programmer device.

"Patients are seeking digital options to better engage with their healthcare providers and manage their chronic conditions remotely—and this has never been more evident than in today's pandemic where virtual care is necessary," said Keith Boettiger, vice president of Abbott’s neuromodulation business.

The NeuroSphere management platform, first launched in May, is compatible with Abbott’s Infinity DBS system aimed at Parkinson’s and essential tremor, as well as the company’s Proclaim XR SCS and DRG devices for chronic pain.

"The approval of Abbott's Patient Controller app with personalized access to therapy is a landmark event, as we are now able to provide patients a way to access personalized therapy from a compatible and secure iOS device so that people can live their lives and seamlessly manage conditions like chronic pain and movement disorders," Boettiger said. The company said it plans to launch the app in the coming weeks.

Originally published by
Conor Hale | July 24, 2020
Fierce Biotech

 
 
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Bronze Level Contributor

NuVasive looks set to outperform analyst expectations in the second quarter, adding to evidence of a faster-than-predicted recovery in the medtech sector from COVID-19. In preliminary results shared Monday, spine technology company NuVasive estimated second quarter sales totaled between $202 million and $205 million, following analyst expectations of around $152 million.

The results are better than a mid-quarter update from NuVasive predicted, leading analysts at Needham to calculate that the company may have achieved double-digit growth in June.

Still, the pandemic has done damage. In addition to a 30% year-over-year sales drop, NuVasive reported $20 million to $25 million in charges related to the impact of the outbreak on its inventory and accounts receivable. The company expects the combination of falling sales and the charges to result in an operating loss of $35 million to $40 million.

As a spine surgery specialist, NuVasive is highly vulnerable to the deferral of elective procedures. A slowdown in spine surgeries began in March, causing NuVasive's sales to fall 5% in the first quarter and prompting the company to brace investors for further declines in the second and third quarters. At that time, NuVasive CFO Matt Harbaugh said it would be “dangerous” to extrapolate early signs of a recovery seen in April out to May and June.

Nonetheless, NuVasive shared an update early last month revealing that case volumes fell 70% in April but began to rebound in early May and accelerated throughout the rest of the month. The turnaround led the company to predict second quarter sales would fall less than 45%, provided performance in June was stable. 

On Monday, NuVasive shared preliminary quarterly results that suggest June may have been better than stable. Sales for the second quarter as a whole were down around 30%, based on the preliminary figures. 

In an analysis that takes in NuVasive’s comment about a 70% decline in April and targeted 45% drop for the quarter if June was stable, the Needham analysts calculate that sales actually increased 13% last month. If accurate, the analysts think the finding shows “the procedural backlog is now driving above-normal revenue growth.” However, SVB Leerink analysts calculate sales were down around 10% in June.

Regardless, the cadence of the recovery is in keeping with comments from other medtech companies including Johnson & Johnson and Philips that have shared second quarter results. There is also evidence that NuVasive could be slightly outperforming rivals; sales at J&J’s spine unit fell 36% in the second quarter, compared to a 30% decline at NuVasive.

The company will release a fuller look at how it performed in the second quarter, and potentially share an assessment of third quarter trends, when it posts its final results after market close on Aug. 4.

Based on what NuVasive said Monday, some analysts expect the company to report continued momentum. “For a management team that is known to be very careful in their language/word choice, we think the positive tenor of this commentary could suggest at least some of the improving momentum seen throughout 2Q may be carrying over into July,” analysts at SVB Leerink wrote in a note to investors following the pre-release Monday.

Originally published by
Nick Paul Taylor | July 21, 2020
Medtech Dive

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Gold Level Contributor

The National Institutes of Health diagnostic research competition delivered $500,000 in initial funding, as part of a four-week evaluation to prove the test’s concept and that it can be commercialized at scale. (3M)

3M is working with researchers from the Massachusetts Institute of Technology to develop a fast COVID-19 diagnostic using a simple, paper-based test that they hope will be easy to mass produce.

The test would detect the coronavirus’ antigens, or the specific proteins coating the walls of the virus, providing a result in minutes without needing any laboratory equipment.

The project is also being supported by the National Institutes of Health through its competitive Rapid Acceleration of Diagnostics Tech program launched in early May to help combat COVID-19.

“Our approach is ambitious, but our collective expertise can make a difference for people around the world, so we owe it to ourselves and society to give it our best effort,” said John Banovetz, chief technology officer at 3M.  

The company has paired up with MIT Professor Hadley Sikes and her team at the university’s Department of Chemical Engineering. The Sikes lab focuses on the molecular technologies behind cellulose-based tests, such as robust and affordable paper-strip diagnostics that can spot infectious diseases such as malaria or tuberculosis. The lab is also working to develop DNA methylation tests aimed at cancer.

“There is a pressing need for a highly scalable rapid test,” said Sikes. “We are working with our colleagues at 3M to overcome the challenges to move this research from lab to impact, and find an innovative path forward to manufacture it at scale. Joining forces with 3M and the NIH has greatly enhanced our collective efforts toward swift detection of the virus, and a potential tool to help mitigate and contain this public health crisis.”

The NIH diagnostic research competition, run through the National Institute of Biomedical Imaging and Bioengineering, delivered $500,000 in initial funding for the project, as part of a four-week evaluation to prove the test’s concept and that it can be manufactured and commercialized on a large scale.

If the project succeeds, it will move into a new phase and be fast-tracked through clinical studies and regulatory review, with additional NIH funding available, toward the goal of providing millions of new COVID-19 diagnostic tests by this fall.

Originally published by
Conor Hale | July 14, 2020
Fiercebiotech

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Gold Level Contributor

Courtesy of https://ventecgm.com/

With ventilators in short supply and U.S. COVID-19 cases first surging in mid-March, the coronavirus pandemic gave rise to a cross-industry partnership pairing automaker General Motors with Seattle area medical device company Ventec Life Systems.

Ventec, a small medtech founded in 2012, was operating at full capacity in March producing a few hundred units per month to meet the urgent need for ventilators but lacked the resources and infrastructure to increase production on a massive scale. That's when GM stepped forward offering to help Ventec build the sometimes lifesaving breathing devices at the automaker's parts plant in Kokomo, Indiana.

Within a month, the first ventilators jointly produced by GM and Ventec were delivered to hospitals in the Chicago area, according to Dan Purvis, CEO of Houston-based engineering firm Velentium, whose company provided the automated testing systems to ensure the ventilators worked as designed.

Nonetheless, Purvis acknowledged the partnership encountered difficult manufacturing challenges early on as GM worked to ramp ventilator production from zero to 10,000 machines per month.

To state the obvious: GM is not a medical device manufacturer. It makes cars, and the scale and speed for producing the ventilators was unprecedented, Purvis observed. At the same time, he credited GM's expertise in "high-scale" manufacturing and having the purchasing power and resources of a large corporation that are "nearly second to none" as the critical ingredients for an undertaking of this size and scope.      

GM and Ventec executives had their first conference calls in mid-March to discuss how the two companies could work together to ramp up production of the ventilators, Purvis recalled. That led to a March 20 face-to-face meeting between execs at Ventec's facility in the Seattle area, only three weeks and nine miles away from the nursing home where the first fatal U.S. cases of COVID-19 occurred, he pointed out during an interview with MedTech Dive.

"Four executives from GM showed up and within the first 30 minutes of them being in the building it was very obvious to me, in my 26-year career, that these people had the resources, the intensity and the intention to make a huge dent in this problem," said Purvis, who attended the meeting at Ventec's Bothell, Washington, headquarters.   

Within days of that March 20 meeting, GM had engaged its global supply base, developed plans to source all the necessary parts for the ventilators, and begun preparing the automaker's closed Kokomo facility for retooling to accommodate ventilator manufacturing.

The White House had been preparing to announce the GM-Ventec venture, called Project V, that called for the production of as many as 80,000 ventilators. However, a March 26 New York Times report said federal support for the GM-Ventec partnership was called into question after the Federal Emergency Management Agency (FEMA) weighed whether the project's $1 billion price tag was too expensive, with several hundred million dollars to be paid upfront to retool GM's Kokomo plant.

After weeks of pressure to utilize the power, President Donald Trump invoked the Defense Production Act (DPA) on March 27.  

"GM was wasting time," Trump said in a statement regarding his use of the Korean War-era law to require the automaker "accept, perform, and prioritize federal contracts for ventilators."  

Originally published by
Greg Slabodkin | July 13, 2020
Medtech Dive

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Gold Level Contributor

Getty Images

Microchips embedded in RFID tags can track and authenticate vaccines, test kits, medical equipment and PPE from manufacturing to clinic sites.

Radio-frequency identification (RFID) technology made a comeback in recent years, in retailairline logistics and baggage tracking and in healthcare.

Now it’s being used in the fight against COVID-19.

Microchips embedded in RFID tags can track and authenticate the vaccine journey from manufacturing to clinical site, along with antibody test kits, personal protective equipment (PPE), medical equipment and high value drug treatments.

RFID is even monitoring some healthcare clinicians' use of hand-washing equipment.

The technology has widespread applications in medical supply chains, and its ability to track and transfer data in real time helps managers maintain visibility during the rapidly changing coronavirus pandemic. 

1. RFID authenticates test kits and PPE

Blockchain company SUKU partnered with Smartrac, an Avery Dennison company, to digitally verify and authenticate COVID-19 test kits and PPE using a near field communication (NFC) RFID tag. The data feeds into Avery Dennison’s Digital Identity Platform, which integrates with SUKU’s blockchain-based supply chain application.

The tags allow the test kits to be authenticated as Food and Drug Administration (FDA)-approved and from a legitimate source. The HIPAA-compliant platform also provides test results, which clinicians with permission can access for greater visibility. The platform can identify COVID-19 hotspots, Amir Khoshniyati, NFC business lead at Avery Dennison, told Supply Chain Dive.

The partnership supplies approved vendors with the NFC RFID tags to use on specific products like test kits. If a manufacturer receives 10,000 tags, it has factory control and traceability over those kits, Khoshniyati said. If there’s an overrun of 1,000 kits, the extra kits are still authentic but won’t have NFC tags. The tags are a way to control distribution and identify who is allowed to sell the items.

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Originally published by
Deborah Abrahams Kaplank | July 10, 2020
Health Care Dive

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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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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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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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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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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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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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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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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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