Nirmidas Biotech announced this week that it received FDA emergency use authorization (EUA) for its COVID-19 test in point-of-care settings. Palo Alto, Calif-based Nirmidas Biotech’s MidaSpot rapid COVID-19 antibody combo detection kit uses fingerstick serology testing to detect IgG/IgM antibodies related to the SARS-CoV-2 virus causing COVID-19, according to a news release. MidaSpot, touted by […]
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.
Hologic says revenue nearly doubled in Q1
Hologic (NSDQ:HOLX) announced today that its revenues nearly doubled year-over-year in the first quarter of fiscal 2021. Marlborough, Mass.-based Hologic expects to report revenues of more than approximately $1.6 billion, an increase of 89.3% from the first quarter of 2020. That tops the company’s November guidance of between $1.35 billion and $1.425 billion for the quarter […]
FDA authorized more than 300 COVID-19 tests and collection kits in 2020
The FDA says it authorized more than 300 COVID-19 test and collection kits in 2020. COVID-19 first made waves at the end of 2019 but began to spread throughout the U.S. in the early months of 2020. As the country faced a pandemic, a number of companies developed diagnostics in an effort to slow the […]
FDA warns on false negatives with Curative COVID-19 test
The FDA yesterday alerted healthcare providers and patients that there is a risk of false results with the Curative SARS-CoV-2 test. The Curative SARS-CoV-2 assay is authorized for prescription-only use as a real-time RT-PCR test used to detect the virus causing COVID-19. The test analyzes throat swabs, nasopharyngeal swabs, nasal swabs and/or oral fluid specimens […]
MedTech 100 roundup: Ringing in the New Year with another high
For the third time in the past four weeks, stocks within the medtech industry climbed to never-before-seen heights as 2021 reared its head. Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), […]
AstraZeneca vaccine recipients in U.K. will wait up to 12 weeks for second dose
An inexpensive COVID-19 vaccine from AstraZeneca (LON:AZN) — now authorized in the U.K. — could go on to become the most widely used in the world. It is inexpensive and easy to produce. But a major hurdle that could slow its rollout in the U.K. after yesterday’s approval is the question of how to best […]
Biden to bolster COVID-19 vaccine production with Defense Production Act
Joe Biden is reportedly planning on invoking the Defense Production Act to shore up the production of COVID-19 vaccines in the U.S. While FDA has authorized the distribution of vaccines from Moderna Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX), distribution has been patchy thus far. Get the full story at our sister site, Pharmaceutical […]
How the clinical trial industry is making the most of COVID-19 disruption
Like most things in healthcare, clinical trials have been slow to evolve in recent decades. But the COVID-19 pandemic has forced clinical trial research teams to become more efficient, patient-centered and inclusive. Much is at stake as the pandemic has already caused significant clinical trial disruption. EY estimates that the COVID-19 impact on Phase 3 […]
Atlanta company says its pulse oximeter works with all skin tones
Safe Heart USA claims that its pulse oximeter proved to be 100% more accurate than comparable devices in an analysis by the FDA. Atlanta-based Safe Heart’s iOX smartphone pulse oximeter combines hardware and software technology to accommodate individual skin tone and blood flow, according to a news release. The iOX is powered through the audio […]
Why AstraZeneca and Sinovac’s COVID-19 vaccines have similar data challenges
A vaccine jointly developed by Oxford University and AstraZeneca (LON:AZN) is on the cusp of authorization in the U.K., according to media reports. Meanwhile, health officials in Turkey and Brazil have indicated that a vaccine from the Chinese firm Sinovac is safe and effective. But one factor that could slow the deployment of both vaccines globally is […]
MedTech 100 roundup: Holidays bring another industry highpoint
Not to be outdone by the previous week’s performance, the medtech industry’s stocks hit yet another peak over the holidays this week. Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and […]