While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while […]
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.
Former FDA commissioner Kessler to help lead Biden’s COVID-19 response
President-elect Joe Biden today announced that Dr. David Kessler, who led FDA through much of the 1990s, will serve as chief science officer of his administration’s COVID-19 response. Kessler’s achievements at FDA included speeding the approval of drugs to reduce the AIDS death toll. He’ll now be helping to lead efforts to speed authorization and […]
Facial swelling and COVID-19 vaccines: 4 facts
Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) […]
Norway investigating deaths of 23 individuals who received COVID-19 vaccine
In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly […]
What’s next for the FDA and for Stephen Hahn?
Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year. It’s hard to blame him. Hahn’s brief tenure at FA has been rocky, to say the least. Get the full story on our sister site, Medical Design & Outsourcing.
FDA grants EUA for RapCov rapid COVID-19 antibody test
Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody test. Malvern, Penn.-based Advaite’s rapid response IgG antibody test uses fingerstick whole blood in point-of-care settings and is touted as capable of providing results in 15 minutes, according to a news release. All RapCov rapid COVID-19 test kits are […]
How Abbott stayed two steps ahead of COVID-19
Developing a fast COVID-19 that resembled a pregnancy test and building two factories to boost production — those were but two of the quick-thinking actions that Abbott (NYSE:ABT) officials took in the early months of a deadly coronavirus pandemic. Abbott began tracking the virus in China at the end of 2019 and into early 2020. By […]
EY says COVID-19 stunted medtech M&A in 2020, should see improvement in 2021
Ernst & Young today released its 2021 EY M&A Firepower report, revealing a staggering dip in mergers and acquisitions (M&A) activity in medtech. Life sciences M&A activity totaled $159 billion in 2020, according to the report — a plunge to nearly half of the 2019 total of $306 billion, representing one of the lowest levels […]
MedTech 100 roundup: Industry skyrockets as hot streak continues
The medtech industry’s seemingly unstoppable rise over the past several weeks shows no signs of slowing down. For the fourth time in five weeks, and for the third consecutive week, the MassDevice MedTech 100 Index — which includes stocks of the world’s largest medical device companies — hit an all-time high. Previous highs have largely been […]
FDA warns about COVID-19 molecular test false negatives as virus mutates
The FDA is warning that false negatives may occur with molecular tests used to detect SARS-CoV-2 if a mutation has occurred in the virus’s genome. According to the FDA, the warning comes as public health officials warn about the new B.1.1.7 variant that appears to be more transmissible than the COVID-19 virus from 2020. Three […]
CES 2021: Medical technologies you need to know
There are fewer mobile health devices and wearables to check out as this year’s CES goes virtual — with a trend toward medtech to slow the spread of COVID-19. Scheduled for Jan. 11–14, CES 2021 will feature 419 digital health and 219 wearable devices, down from 546 and 635 devices, respectively, presented at CES 2020. […]