Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway Sparrow ventilators. The 2.2 lb. transport and emergency ventilators had previously won FDA emergency authorization for use during the COVID-19 public health emergency. They are already commercialized in Europe, Canada and Australia and are undergoing registration procedures in other countries, according to […]
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.
Biden administration orders home COVID-19 tests
The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test. In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 […]
Roche obtains CE Mark for rapid COVID-19 test with easier nose collection
Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test. Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified […]
MedTech 100 roundup: January ends with a dip
After spending several weeks on the ascent, medtech stocks leveled out a bit to end January, ending a run of several new highs in 2021. MassDevice‘s MedTech 100 index ended the week (Jan. 29) at 104.05 points, marking a -2.2% drop from the 106.4-point mark set at the end of the previous week (Jan. 22). The […]
4 ways COVID-19 variants could change the battle against the pandemic
Highly-transmissible COVID-19 variants have likely been circulating undetected for months in places like the U.K., South Africa and Brazil. They then seemed to burst onto the scene, fueling large outbreaks that dwarfed preceding ones. While the variants aren’t well understood, they suggest that SARS-CoV-2 is mutating in ways that confer an evolutionary advantage. They thus […]
10 medtech hazards you need to watch out for in 2021
Patient safety organization ECRI comes out with its list of health technology hazards every year, and it often contains the same issues. The COVID-19 pandemic has changed much of that. The nonprofit organization is focusing this year on the need to move from trying to cope during an emergency to building stronger and more resilient […]
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of […]
Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants
A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants. The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in […]
NeuroMetrix slides on Q4 losses
NeuroMetrix (NSDQ:NURO) shares dipped today on fourth-quarter results that showcased losses despite an improved bottom line. The Woburn, Mass.-based company posted losses of -$325,767 on sales of $1.8 million for the three months ended Dec. 31, 2020, for a 69.2% bottom-line gain on sales growth of 6%. NeuroMetrix experienced headwinds from the COVID-19 pandemic and felt […]
Danaher rises on Street-beating Q4
Danaher (NYSE:DHR) shares ticked up this morning on fourth-quarter results that topped the consensus forecast. The Washington, D.C.-based company posted profits of $1.2 billion, or $1.66 per share, on sales of $6.8 billion for the three months ended Dec. 31, 2020, for a -4.8% bottom-line slide on sales growth of 38.9%. Adjusted to exclude one-time items, […]
Abiomed skyrockets on Street-beating Q3
Abiomed (NSDQ:ABMD) shares shot up this morning on third-quarter results that topped the consensus forecast. Shares of ABMD were up 12.4% at $369.45 per share in early-morning trading today. The Danvers, Mass.-based oxygenation device maker posted profits of $61.9 million, or $1.35 per share, on sales of $231.7 million for the three months ended Dec. 31, […]