FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website. Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision […]
Dept. of Health & Human Services (HHS)
Report: Ventilators are piling up in government stockpiles
As the COVID-19 pandemic roars on, the government stockpile of once-in-demand ventilators has reportedly turned into a collection of unused devices. The Washington Post reports that, following the panic caused by an anticipated ventilator shortage and subsequent rush to add to the stockpile after President Trump invoked the Defense Production Act, the approach to treating COVID-19 […]
Feds ink COVID-19 vaccine distro deal with McKesson
The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a COVID-19 vaccine distribution deal with McKesson. Under Operation Warp Speed, McKesson will become a central distributor of future COVID-19 vaccines and related supplies needed to administer the pandemic vaccinations, according to a news release. Get the full story at our sister […]
MedTech 100 roundup: Up-and-down week for industry
Medtech stocks highlighted the topsy-turvy nature of the market last week, but ultimately finished the seven days nearly unchanged. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.77 points at the end of last week (Aug. 14). Overall, medtech stocks saw a 0.13% increase from the […]
DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production
The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test. Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release. BioFire’s COVID-19 test received FDA emergency use authorization […]
U.S. to spend $1B for doses of J&J’s COVID-19 vaccine candidate
The U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for a vaccine candidate from Johnson & Johnson (NYSE:JNJ). HHS and DoD announced the agreement with Janssen Pharmaceutical, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of its COVID-19 vaccine candidate, with the federal […]
NIH puts $249m into new COVID-19 tests
The National Institutes of Health (NIH) announced today that it is investing $248.7 million in new technologies to address challenges with COVID-19 testing. The “Rapid Acceleration of Diagnostics” (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by […]
U.S. government agencies announce COVID-19 Insights Partnership
The U.S. Dept. of Energy, Dept. of Health and Human Services and Dept. of Veterans Affairs announced today that they formed a COVID-19 Insights Partnership. According to a news release, the trio of government agencies formed the partnership as an initiative to coordinate and share health data, as well as to research the virus and […]
HHS, DOD invest $7.6m in Hologic COVID-19 test samples
The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a $7.6 million contract for COVID-19 testing from Hologic (NSDQ:HOLX). Marlborough, Mass.-based Hologic will receive the contract with a ceiling of $7.6 million so it can expand production of custom sample collection and processing consumables for COVID-19 testing, according to a news […]
HHS taps Pfizer to produce millions of COVID-19 vaccine doses
Two U.S. government agencies today announced an agreement with Pfizer (NYSE:PFE) for production and delivery of 100 million doses of a COVID-19 vaccine. The U.S. Dept. of Health and Human Services, along with the U.S. Defense Dept., agreed to the large-scale production and U.S. delivery deal once Pfizer’s vaccine is successfully manufactured and approved. In addition to […]
MedTech 100 roundup: Industry hits pandemic peak
After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% […]