For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
HHS gives Vaxxas $22M to support vaccine patch tech
Vaxxas announced today that it has received a $22 million award from the Biomedical Advanced Research and Development Authority (BARDA) at U.S. HHS to support a clinical study involving the company’s vaccine-delivery patch. The money will mostly pay for a Phase 1 clinical study in which Vaxxas’ high-density micro-array patch (HD-MAP) delivering pandemic influenza vaccine to […]
FDA’s Hahn insists a COVID-19 vaccine approval will not be rushed
FDA Commissioner Dr. Stephen Hahn used a virtual conference appearance today to repeat that a COVID-19 vaccine approval will be up to the agency’s scientists — not political pressure. “We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held […]
MedTech 100 roundup: Industry rises week-over-week
The medtech industry hasn’t reached the heights of early September but continues to tick back up over time in the stock market. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 89.73 (Oct. 2), marking a 1.9% gain from the 88.05 points registered at the […]
LabCorp molecular COVID-19 testing method wins FDA EUA
Laboratory Corporation of America (NYSE:LH) announced today that received FDA emergency use authorization for its new COVID-19 testing method. Burlington, N.C.-based LabCorp’s new, high-throughput method uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing in an effort to improve the speed and efficiency of RT-PCR tests for the virus, according […]
AdvaMed pushes for Medicare coverage of digital health tech
Medtech trade group AdvaMed today called on the federal government to expand Medicare coverage to digital health technologies. The Medicare statute does not directly address coverage of digital health technologies, nor does it specifically limit or prohibit their coverage. But it doesn’t make Medicare coverage easy, either. Get the full story on our sister site, […]
Report: FDA expanding AstraZeneca vaccine probe
The U.S. FDA is reportedly expanding its probe into a serious illness arising in the COVID-19 vaccine study from AstraZeneca (NYSE:AZN). This news, reported by Reuters, follows last week’s statement from U.S. Health and Human Services Dept. Secretary Alex Azar that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in […]
FDA authorizes first oral-rinse COVID-19 diagnostic
Access Genetics & OralDNA Labs announced today that it received FDA emergency use authorization (EUA) for its oral-rinse COVID-19 test. Eden Prairie, Minn.-based Access’ OraRisk COVID-19 RT-PCR test allows for testing from a saline oral rinse collection. Samples of the test are viable for up to 72 hours and don’t require cold pack transportation while […]
BD wins CE mark for 15-minute COVID-19 diagnostic test
Becton Dickinson (NYSE:BDX) announced today that it received CE Mark approval in Europe for its rapid COVID-19 test. Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test — used on the BD Veritor Plus system — delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a […]
Report: Canada to buy 7.9M Abbott COVID-19 tests
The Government of Canada announced today that it agreed to buy up to 7.9 million Abbott (NYSE:ABT) ID NOW rapid point-of-care COVID-19 tests. Canadian Minister of Public Services and Procurement Anita Anand, along with Minister of Health Patty Hajdu, announced the agreement for the tests, although the purchase still hinges on Health Canada authorization for the […]
Feds shipping 100M of Abbott’s rapid COVID-19 tests to states
The U.S. federal government has started shipping 100 million of the Abbott (NYSE:ABT) rapid COVID-19 tests to states to support school reopenings and more. “For example, the support my administration is providing would allow every state to, on a very regular basis, test every teacher who needs it. This continues our critical effort to use testing […]