FDA removes eight software functions from medical “device” classification
April 19, 2021 – The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act….
JHC’s Dail-eNews
Pfizer, BioNTech to supply EU with 100 million additional doses of COVID vaccine
April 19, 2021 – Pfizer Inc. and BioNTech SE announced they will supply an additional 100 million doses of COMIRNATY, the companies’ COVID-19 vaccine, to…
Abbott begins shipping BinaxNOW COVID-19 Ag Self Test to retailers
April 19, 2021 – Abbott (Abbott Park, IL) announced it began shipping its BinaxNOW COVID-19 Ag Self Test to retailers across the U.S. Consumers can…
Lake Health officially joins University Hospitals system
April 19, 2021 – University Hospitals (UH) (Cleveland, OH) and Lake Health (Concord, OH) have completed membership substitution which officially makes Lake Health a member…
HHS eliminates “flawed” plan to let some devices skip review
April 16, 2021 – The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion…
Third dose of COVID-19 vaccine “likely” needed within 1 year
April 16, 2021 – Pfizer CEO Albert Bourla said Thursday that COVID-19 vaccine recipients will likely need a third dose between six to 12 months…
Baylor Scott & White Health names new CFO
April 16, 2021 – Baylor Scott & White Health (Dallas, TX) has hired Jennifer Mitzner as EVP and CFO, effective June 1, 2021. In this…
Thermo Fisher Scientific to acquire PPD, Inc. for $17.4B
April 16, 2021 – Thermo Fisher Scientific Inc. (Waltham, MA) will acquire and PPD, Inc. (Wilmington, NC) for a total cash purchase price of $17.4…
Mayo Clinic launches two new tech companies
April 15, 2021 – Mayo Clinic has announced a new technology platform initiative to new clinical decision support tools, diagnostic insights, and care recommendations to…
Atrium Health opens new $228M plaza for heart care in Charlotte
April 15, 2021 – Atrium Health has opened new, state-of-the-art facilities in Charlotte, North Carolina. Atrium Health Kenilworth Medical Plaza I and II is an…