The FDA’s vaccine advisory committee voted 17-4 with one abstention Dec. 10 to recommend an emergency use authorization (EUA) for the Pfizer Inc./Biontech SE mRNA vaccine BNT-162b2 to prevent COVID-19 in individuals 16 and older.
The COVID-19 pandemic has been more than just a distraction for the U.S. FDA, which started 2020 with a number of ambitions regarding digital health regulation. Despite having unveiled the Digital Health Center of Excellence to great fanfare, the agency is struggling to wrap up major digital health programs, such as the precertification program for software as a medical device, leaving the FDA with a daunting agenda for digital health in the coming year.
The U.S. FDA has made it easier for people who want to get tested for COVID-19, granting emergency use authorization (EUA) for direct-to-consumer sales of Laboratory Corp. of America Holdings’ (Labcorp) Pixel COVID-19 test home collection kit. With this latest EUA, any individual 18 years and older can purchase the Pixel test system without a prescription.
The U.S. FDA authorized Burlington, N.C.-based Laboratory Corporation of America Holdings’ (Labcorp’s) Pixel COVID-19 test home collection kit for use by any individual 18 years and older without a prescription.
The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall.
The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics Inc. and Freespira Inc. as both companies announced good news. Mahana's prescription digital therapeutic for gastrointestinal conditions, Parallel, received premarket authorization from the U.S. FDA and Freespira, formerly Palo Alto Health Sciences Inc., raised $10 million for its digital therapeutic for panic attacks, panic disorder and post-traumatic stress disorder.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs.
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