50 startup companies selected by MedTech Innovator for program

BARDA awards $718K to Empatica for wearable physiological monitor | COVID-19 lessons learned: Supply chain management may never be the same | Focused ultrasound method useful in glioblastoma

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June 23, 2020

News for medical technology professionals

Top Story

50 startup companies selected by MedTech Innovator for program

MedTech Innovator has selected 50 startup companies to participate in its four-month showcase and accelerator program. At The MedTech Conference led by AdvaMed, the program will award approximately $500,000 in cash and in-kind prizes during the final competition.

Full Story: MassDevice (Boston) (6/22)

	New Regulations Require New Operating Models Critical requirements to stay compliant for medical device & diagnostics companies are essential to succeed in an increasingly complex global regulatory environment. New processes stay up to date on regulatory changes and improve efficiency through data-sharing. Download the whitepaper to improve "business-as-usual" practices.

Business & Market Trends

BARDA awards $718K to Empatica for wearable physiological monitor

The Biomedical Advanced Research and Development Authority has given approximately $718,000 to Empatica to help validate its Aura system, a wearable physiological monitor that can help in the early detection of COVID-19.

Full Story: MedTech Dive (6/22)

	COVID-19 Impact for the IVD Industry COVID-19 has put a spotlight on In Vitro Diagnostics (IVD), with the rapid development of diagnostics. But the industry is facing challenges as the demand for other tests are down. Get the whitepaper to learn how the industry can emerge stronger.

Fresh Look with Medical Design & Outsourcing

COVID-19 lessons learned: Supply chain management may never be the same

Two manufacturers, a healthcare system and a logistics company share some of the wisdom they gained from supply chain challenges they faced during the height of the pandemic. Read more.

Science & Health

Focused ultrasound method useful in glioblastoma

Researchers found that combining focused ultrasound and the breakthrough drug 5-ALA led to a 47% decline in living glioblastoma cells, compared with a 16% and 5% drop using either focused ultrasound or the drug alone, respectively. The approach, described in the Journal of Neuro-Oncology, "has the potential to improve outcomes for patients with complex brain tumors and other neurosurgical pathologies," researcher Jason Sheehan said.

Full Story: Health Imaging online (6/22)

Emerging Technologies

Researchers create low-cost antibody test

Researchers from the University of Nebraska at Lincoln have created a fast, low-cost antibody test that can be used to detect COVID-19 as well as potentially other viruses and infectious diseases.

Full Story: KETV-TV (Omaha, Neb.) (6/22)

Government & Regulatory

EU expands approval for Medtronic's TAVI system

Medtronic's Evolut transcatheter aortic valve implantation system has been given CE mark approval in patients with a low risk of surgical mortality who have severe native aortic stenosis.

Full Story: MassDevice (Boston) (6/22)

Personalized knee system from Conformis cleared

The FDA has given 510(k) clearance to Conformis for its iTotal Identity PS Knee System. "Having a Posterior Stabilized (PS) option for our Identity system will allow surgeons to treat a wider range of patients more effectively," said Mark Augusti, Conformis' president and CEO.

Full Story: MassDevice (Boston) (6/22)

Ventilator from BYU gets EUA

The AdultLife Ventilator, a low-cost, compact ventilator made by students and alumni from Brigham Young University, has been given emergency use authorization by the FDA.

Full Story: KUTV-TV (Salt Lake City) (6/22)

FDA rescinds Chembio's EUA for coronavirus antibody test

Chembio's emergency use authorization for its coronavirus antibody test has been revoked after independent FDA testing found "poor device performance observed in multiple evaluations since authorization," according to a letter from Denise Hinton, the FDA's chief scientist. The company's test was one of the first issued an EUA by the FDA and was used to test about 700 nursing home residents and staff on Staten Island.

Full Story: Staten Island Advance (N.Y.) (6/22)

FDA approves back pain device from Mainstay Medical

Mainstay Medical has received premarket approval from the FDA for its Reactiv8, a neurostimulation system implant that is used to treat chronic low back pain.

Full Story: FDAnews (6/23)

Hip surgery navigation system from Naviswiss cleared

Naviswiss has received FDA clearance for its navigation technology that is used during hip replacement surgery.

Full Story: Becker's Spine Review (6/22)

AdvaMed Events and Education

Advertising and Promotion of Medical Devices Webinar Series

While the current global health crisis prevents us from hosting this year's Advertising and Promotion of Medical Devices Conference, we are pleased to deliver some of the most timely content in a virtual format. This three-part webinar series will highlight essential topics, including AdvaMed's direct-to-consumer principles, current social media considerations and important legal and regulatory boundaries. Learn more.

New AdvaMed COVID-19 Resource Center now available

With our member companies on the front lines of the fight against the COVID-19 pandemic, AdvaMed is working diligently to address the medtech industry's needs and provide resources that support you and your businesses during this challenging time. To better support you, we have launched a new COVID-19 Resource Center to provide important information to companies about the federal response to COVID-19, best practices and other valuable resources. Learn more.