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medtech (24)

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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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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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."

Read more

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

 

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Silver Level Contributor

Credit: Joseph Fuqua II/UC Creative + Brand

 

The University of Cincinnati won a national grant to develop reusable facemasks that are sterilized with heat

 

Engineers at the University of Cincinnati are using a National Science Foundation grant to develop a face mask that can be sterilized with heat for re-use.

 

“Currently, there is a significant shortage of personal protective equipment, particularly face masks, due to the COVID-19 pandemic in the United States. Statistics show that one COVID-19 patient consumes on average 17 face masks per day worn by medical personnel,” said the principal investigators of the study, Vesselin Shanov, professor of chemical engineering, and Soryong “Ryan” Chae, assistant professor of environmental engineering.

With face masks in high demand – and an expectation that the widespread need for masks will continue as the virus persists – Shanov and Chae saw an opportunity to make an impact.

Read more here

 

Originally posted by:
bioengineer.org
May 28th, 2020

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Silver Level Contributor

Credit: University of Miami Health System

 

University of Miami Health System researchers publish commentary in Lancet Psychiatry

 

The COVID-19 pandemic is stressful enough, but for children and adults with autism spectrum disorder (ASD) and their families, the crisis can be especially difficult.

Adrien A. Eshraghi, M.D., M.Sc., professor of Otolaryngology, Neurological Surgery and Biomedical Engineering, has dedicated much of his career to caring for individuals with various disabilities including individuals with autism, who are very dear to him.
 

Dr. Eshraghi and Miller School coauthors published a new correspondence titled COVID-19: overcoming the challenges faced by individuals with autism and their families in The Lancet Psychiatry*. In this commentary, the authors address specific challenges patients with autism and their families might encounter during the pandemic, as well as what healthcare providers should know and do to ensure optimal and safe care.

Chances are good that providers caring for COVID-19 patients in all settings, including the emergency room (ER) and inpatient settings, will encounter adults and children with autism.

“Autism spectrum disorder prevalence has increased significantly in the last 20 years. In 2004, the prevalence of autism was 1 in 166. Today the Centers for Disease Control (CDC) estimates that 1 in 54 children are on the autism spectrum”, according to Dr. Eshraghi, who also is the director of the University of Miami Hearing Research and Communication Disorders Laboratory and co-director of the University of Miami Ear Institute.

Read more here

 

 

Originally posted by:
bioengineer.org
May 21st, 2020

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Silver Level Contributor

A patient having blood drawn for a Covid-19 antibody test. Photo credit: Pier Marco Tacca, Getty Images.

 

Verily, Alphabet’s life sciences arm, is launching a new study to better understand the immune response to Covid-19 and gain more information on the accuracy of tests.

Alphabet’s life sciences arm, Verily, is launching a new study to better understand the immune response to Covid-19.  The study, called Baseline Antibody Research, will offer serology testing to people who have already received a Covid-19 nasal swab test through Verily.

In March, Google’s sister company began screening for potential Covid-19 cases and connecting people to tests. The project was initially limited to San Francisco, but has since been expanded to more locations in California and 12 additional states through a partnership with Rite Aid.

With this new study, Verily will focus on antibody testing. The information could be useful in gleaning important information about immunity and helping track whether previous tests were effective in detecting the virus. 

Read more here

 

 

Originally posted by:
Elise Reuter
Medcitynews.com
May 18th, 2020

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Silver Level Contributor

Credit: Phil Jones, Senior Photographer, Augusta University

 

A group of tiny RNA that should attack the virus causing COVID-19 when it tries to infect the body are diminished with age and chronic health problems, a decrease that likely helps explain why older individuals and those with preexisting medical conditions are vulnerable populations, investigators report.

MicroRNAs play a big role in our body in controlling gene expression, and also are a front line when viruses invade, latching onto and cutting the RNA, the genetic material of the virus, says Dr. Sadanand Fulzele, aging researcher in the Department of Medicine and Center for Healthy Aging at the Medical College of Georgia at Augusta University.

But with age and some chronic medical conditions, the attacking microRNA numbers dwindle, reducing our ability to respond to viruses, says Dr. Carlos M. Isales, co-director of the MCG Center for Healthy Aging and chief of the MCG Division of Endocrinology, Diabetes and Metabolism.

Read more here

 

 

Originally posted by:
bioengineer.org
May 13th, 2020

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Silver Level Contributor

A new report by Strata indicated that health systems are already beginning to see the effect of the boom in unemployment as a result of the Covid-19 pandemic. Nearly 15% of the surveyed hospitals’ patients in early May were uninsured or self-pay patients.

With the Covid-19 pandemic creating the worst unemployment levels since the Great Depression, states are preparing for a drop off in the number of people with health coverage. Hospitals are already beginning to see the effects as they treat more uninsured patients, according to a report by Strata Decision Technology.

Unemployment rates reached 14.7 percent in April, according to the latest available data from theBureau of Labor Statistics. Hospitals, meanwhile, have seen a steady uptick in the number of uninsured or self-pay patients in the last three months. 

Read more here

 

Originally posted by:
Elise Reuter
medcitynews.com
May 11th, 2020

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Silver Level Contributor

Credit: University of Michigan

 

Food insecurity disparities by age, health status, race, ethnicity & education seen in National Poll on Healthy Aging; pandemic may have worsened them.

Even before the coronavirus pandemic wreaked havoc with the nation’s food supply and economy, one in seven adults between the ages of 50 and 80 already had trouble getting enough food because of cost or other issues, a new poll finds.

The percentage who said they’d experienced food insecurity in the past year was even higher among those in their pre-Medicare years, and those who are African-American or Latino. Older adults with lower household incomes and lower levels of education were also more likely to say they had had trouble getting food.

Read more here

 

Originally posted by:
bioengineer.org
May 11th, 2020

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Silver Level Contributor

PhotoPharmics has raised $11 million and aims to raise another $10 million to help in the development and commercialization of its specialized light therapy device to treat Parkinson's Disease.

The Food and Drug Administration recently awarded a breakthrough device designation for a phototherapy device intended to help patients with Parkinson’s Disease.

The non-invasive device is made by American Fork, Utah-based PhotoPharmics and is meant to be used at home, explained Kent Savage, CEO of PhotoPharmics, in an email response. The company’s website and press release claims that this is the first specialized light therapy device to receive such a priority designation for the FDA reserved for novel devices trying to fulfill an unmet patient need.

Read more here

 

Originally posted by:
ARUNDHATI PARMAR
medcitynews.com
May 7th, 2020

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Silver Level Contributor

Real-time technologies provider BATM has announced that its Adaltis subsidiary has launched ELISA Serological Test Kits that diagnose if a patient has had COVID-19 by detecting antibodies against it present in their blood.

The Adaltis Serological Tests are fully CE certified and the Group has started shipping initial orders. It is now increasing production for larger quantities to fulfil further orders received from these customers.

The ELISA serological test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself – to help identify those who have been infected and developed antibodies that may protect them from future infection.

Adaltis’ ELISA Serological Tests for COVID-19 are designed to test for IgA and IgM as well as IgG antibodies. Adaltis’ tests can be conducted both on standard ELISA machines that are already in use in laboratories and hospitals, and on Adaltis’ Personal LAB and NEXgen machines, which are pre-calibrated for these tests.
 

Read more here

 

Originally posted by:
med-technews.com
May 6th, 2020

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Silver Level Contributor

Credit: University of Leeds

Scientists have identified a key process in the way bacteria protect themselves from attack – and it heralds a new strategy in the hunt for antibiotics.

The researchers from the University of Leeds have pieced together how bacteria build their outer, defensive wall – in essence, the cell’s armour plating.

The research has focused on the gram-negative bacteria Escherichia coli, but the process they have discovered is shared by many pathogenic gram-negative bacteria – so it could have importance for tackling other gram-negative pathogens, including the top three on the World Health Organisation’s list of priority pathogens.

The findings are published today (01/05) in the journal Nature Communications.

Read more here

 

Originally posted by:
bioengineer.org
May 1st, 2020

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Silver Level Contributor

Coronavirus: A catalyst for change?

The coronavirus crisis demands a coming together to reach goals for the common good. This requires a fundamentally new way of working, one that, in our opinion, holds the key to solving healthcare's broader issues.

Coronavirus dominates every conversation as the world grapples with the magnitude of the Covid-19 pandemic. But policymakers and healthcare actors dare not simply wish for warmer weather or hope to “ride this one out.” Amidst the confusion and chaos lies an unparalleled opportunity to tap into the immense momentum generated by this crisis and usher in transformational changes to the healthcare sector that are long overdue. 

The coronavirus crisis exposes the limits of our current healthcare systems in dramatic fashion. For instance, in the U.S., an early response was slowed by issues ranging from approvals for diagnostic testing in hospitals rather than at the CDC, to contamination of testing kits at the CDC and patient eligibility for screenings. As director of the National Institute for Allergy and Infectious Disease, Tony Fauci, previously put it nearly a month ago “the system is not really geared to what we need right now, what you’re asking for [rapid deployment of testing]. That is a failing.” Unfortunately, the legacy of these early missteps may be what slows the country down from reopening, as testing availability is critical for plans to ease social distancing measures.

Read more here

 

Originally posted by:
BEN ALSDURF AND THOMAS HAGEMEIJER
medcitynews.com
April 29th, 2020

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Silver Level Contributor

University Hospitals Birmingham NHS Foundation Trust (UHB) and AI specialist Skin Analytics are to pilot a new skin cancer community assessment service to reduce delays in skin cancer detection and treatment during the Coronavirus pandemic.

There are around 8-13 million GP appointments booked for skin cancer assessments every year across the UK. Around 16,200 people are diagnosed with melanoma, which is now the fifth most common cancer in Britain. While 2,300 people die each year, the survival rates improve significantly if the disease is caught early. By introducing a tele-dermatology service, UHB referred patients will have potentially cancerous skin lesions assessed and receive life-saving treatment sooner.

During the pilot, referred patients will be provided with skin cancer triage outside of the hospital setting, using AI technology to capture high quality images of those lesions which may be melanoma and requiring priority investigation by a dermatologist, and those that are safe to defer according to the BAD guidelines. The service will help flatten the demand curve to manage the ongoing clinical risk when social isolation measures are lifted, and the latent demand is released.

Read more here

 

 

Originally posted by:
www.med-technews.com
April 29th, 2020

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Silver Level Contributor

Credit: Dyson

 

The UK government had originally ordered 10,000 CoVent ventilators and the company said it had worked with outside experts from the MHRA and the NHS throughout the design process to allow for quick regulatory clearance in order to increase ventilator capacity in order to tackle to the Coronavirus.

The Dyson CEO and founder said he would hope the ventilators found use in other countries and that the £20 million spent on the project would be funded by himself – meaning he won’t be accepting money from the public purse.

 

Read more here

 

Originally posted by:
med-technews.com
April 27th, 2020

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Silver Level Contributor

An IoT Button that was originally intended for parents to locate their children in the event they were lost or in danger has seen a spike in interest following the Coronavirus outbreak.

In the last eight weeks Secufy has seen enquiries from health organisations across the world looking for solutions to plug critical care communication challenges.

Demand for Secufy’s IoT Button to solve critical use cases within health organisations has meant scaling production 100x in a very short time frame. 

The Secufy Button is being deployed in healthcare scenarios including:

  • Patients who are sent home with weak symptoms after having tested positive for COVID-19 are given a Secufy IoT Button. Should the patient's condition worsen, they press the button which alerts clinicians through a pre-defined comms channel. This circumnavigates normal telephone helplines.
  • The Secufy Button is deployed providing an instant secondary comms infrastructure for nurse call systems within hospitals.
  • The elderly and vulnerable who are self-isolating receive a Secufy Button that cascades an alert to family members in the event of an emergency. 
  • The Secufy Button can also be used to act as a tracker to ensure quarantine is being adhered to or to notify family members if an elderly relative has been out (and not returned).

Read more here

 

Originally posted by:
med-technews.com
April 24th, 2020

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Silver Level Contributor

Innovative medical technologies are set to play a key role in the nation’s COVID-19 response. Dr Kit Latham, CEO of London-based medical HR specialists Credentially, explains why.

 

COVID-19 is the greatest public health challenge the UK has faced in a generation. In order to tackle the pandemic head-on, it’s vital that we mobilise an expanded force of healthcare workers and volunteers as quickly as possible. It has been heartening to see so many people step up to the plate over the last few weeks, but there are still major challenges to overcome in this respect – obstacles that can only be surmounted by harnessing the power of technology.

Unfortunately, the way we traditionally hire healthcare workers could act as a major stumbling block to adequately combatting the virus. The NHS’s hiring process usually takes between three and six months, and for every 10 clinicians that apply for a job in healthcare – not just within the NHS – only five will ever work a shift. Sadly, up to 50% become frustrated and give up on the process.

In the current circumstances, it’s more important than ever to train, on-board and validate staff as swiftly and safely as is practicably possible. These are the hurdles we sought to overcome when we established Credentially. Our signature software makes clinical HR and compliance processes quicker and easier for healthcare workers and their employers, so they can get to the frontline of the COVID-19 response ASAP. The software also reduces the manual work involved in getting a health worker on the shop floor by up to 90%, and – most helpfully in this age of social distancing – it eliminates the need for face-to-face interaction.

Read more here

 

Originally posted by:
Kit Latham
med-technews.com
April 24th, 2020

 

 

 

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Silver Level Contributor

Global cloud communications software and solutions provider IMImobile, has announced its healthcare division, Healthcare Communications, has launched its eClinic software to NHS Trusts for free for a year.

 

The video consultation software allows for patients to see their clinicians via online consultations, from their own homes. This means that regular health checks and medical reporting can continue even if patients or healthcare professionals are self-isolating.

Kenny Bloxham, managing director at Healthcare Communications, said: “We all need to support the NHS through this crisis; by switching as many appointments to virtual as possible, we can ensure services are not overwhelmed in the future. The eClinic solution is clinician led, so patients don’t spend lengthy periods in ‘virtual’ waiting rooms – instead, clinicians can immediately connect with their patient. It can be rolled out at scale across hospitals and GPs within days, and looking to the longer term, represents a sustainable way to redesign the patient pathway for the future.”

 

Read more here

 

Originally posted by:
www.med-technews.com
April 22nd, 2020

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Silver Level Contributor

The Danish Government is launching two new digital solutions to drive the safe and controlled reopening of Denmark, after the government mandated lockdown due to COVID-19.

IT services provider, Netcompany, has developed the broad national emergency applications for use by both the Danish health authorities and citizens, to support Coronavirus efforts, and will be available to the country’s public within two weeks. 

 

COVIDmeter – monitoring the prevalence of COVID-19

COVIDmeter will collect information from citizens about disease symptoms in relation to COVID-19. The new digital solution can be used by all Danish citizens. Login is via a system usually used for online banking. The system can also inform users of up to date information on COVID-19 from the public authorities.

Users will be encouraged to fill out a digital questionnaire about their health on a weekly basis, allowing authorities to assess the development of the epidemic. Symptoms, recovering status after COVID19, and many other data is collected.

The Danish Serum Institute will use the data to monitor the spread of infection in the community. Danish citizens can now sign up for the new COVIDmeter solution at sundhed.dk.

 

Read more here

 

 

Originally posted by:
www.med-technews.com
April 22nd, 2020

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Silver Level Contributor

LIVI is launching UK national guidelines to NHS GPs, to provide training and treatment on how they can spot and manage COVID-19 symptoms in their patients over phone or video.

These directions, which were produced in the absence of national guidelines for COVID-19 and digital healthcare in the UK, have been produced by LIVI’s clinical team of NHS Doctors and in partnership with the NHS.

They will help to ensure that all doctors in the UK can spot early signs of COVID-19 and help them to better understand the pandemic and how it develops.

 

Read more here

 

Originally posted by:
www.med-technews.com
April 21st, 2020

Read more…

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