Qorvo this week said it received FDA emergency use authorization for its Omnia SARS-CoV-2 antigen test. The diagnostic platform uses high-frequency bulk acoustic wave (BAW) sensors to test for COVID-19 antigens in approximately 20 minutes, according to the company. BAW sensors enable a low limit of detection levels that are similar to molecular testing capability. […]
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.
Annual COVID-19 vaccines likely, according to Pfizer CEO
The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today. “It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview. While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on […]
Analysts are bullish on Align Technology
Analysts are bullish on Align Technology (NSDQ:ALGN) after the company has seemingly prospered despite the COVID-19 pandemic. SVB Leerink senior research analyst Richard Newitter explained in an analysis that Align, a maker of clear teeth aligners, is a “unique-in-healthcare” growth asset with an underpenetrated total available market (TAM). Analysts see the company as a relatively […]
EU won’t renew J&J, AstraZeneca vaccine contracts, report says
Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the current year expire, […]
Pfizer to boost vaccine production for U.S. by 10%
Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday. The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot […]
9 things to know as AstraZeneca and J&J COVID-19 vaccines face safety scrutiny
With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus. But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed severe blood clot disorders. Officials in both the […]
Ortho Clinical Diagnostics lands CE mark for high-volume COVID-19 test
Ortho Clinical Diagnostics (NSDQ:OCDX) announced that it received a CE mark for its Vitros SARS-CoV-2 antigen test for COVID-19. European approval follows the Vitros test’s initial launch in October 2020. The CE mark allows for more convenient sample collection and expanded viral transport media, according to a news release. Personnel at hospitals, labs and other […]
Cardinal Health wins $58M federal PPE contract
Cardinal Health (NYSE: CAH) today said it was awarded a $57.8 million contract from the U.S. Dept. of Health and Human Services to support the Strategic National Stockpile. The Dublin, Ohio-based company received the contract, which includes options that if exercised by the HHS could reach $91.6 million, to store and distribute 80,000 pallets of personal […]
Could BrainCheck’s simple test help COVID long-haulers?
BrainCheck’s eponymous mobile neurocognitive test can detect dementia and concussion. But it has a new application: post-COVID brain fog. Developed by neurologists at Baylor College of Medicine’s Eagleman Laboratory for Perception and Action, BrainCheck carries an FDA Class II Software as a Medical Device (SaMD) designation and can be used on a tablet or laptop in […]
Feds halt J&J COVID-19 vaccine due to blood clot concern
The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood […]
FDA issues EUA for single-use, OTC PCR COVID-19 at-home test
Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit. Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the […]