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 […]
COVID-19
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. […]
FDA authorizes fingerstick COVID-19 antibody test
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 […]
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 […]