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Brian Bossetta

Senior Writer, US Policy & Regulation

New York, NY

After moving to New York from his hometown of New Orleans, Brian worked on the East End of Long Island covering news, politics and the military. He has since covered the diamond and jewelry industries and most recently pharmacy and health care. His experience also includes freelance reporting and photography contributed to the New York Times.

Brian holds a BA in history from Loyola University of New Orleans, is a die-hard Saints fan, and loves running, classical music and jazz. He lives with his wife, Caroline, in New York’s magnificent Hudson Valley.

Latest From Brian Bossetta

AI Assisted Ablation Bests Conventional Procedure, Trial Data Shows

A study by French device firm Volta found an AI-guided ablation procedure was more effective in treating patients with atrial fibrillation, especially those whose symptoms had persisted for six months or longer.

Commercial Clinical Trials

Pair Of Deaths Linked To Latest Recall Of Abbott HeartMate Pump

Abbott has issued a recall of several hundred HeartMate 3 pumps used to support patients with heart failure after reports of blood leakage and air entering the devices.

FDA Recalls

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence

FDA Grants De Novo Marketing Authorization For At-Home Retinal Imaging Device

Notal Vision, a Virginia-based patient-centric ophthalmic remote monitoring services provider, has won de novo marketing authorization from the US FDA for a product that allows patients to keep tabs on their age-related macular degeneration while at home.

FDA OTC Devices

‘If It Wasn’t For NeuroStar, I Wouldn’t Be Here Today,’ Says Teen Patient

A panel of mental health experts, advocates, and patients met recently in Manhattan to discuss the promise of the Neuronetics’ NeuroStar transcranial magnetic stimulation system, which the US FDA recently cleared to treat depression in adolescents ages 15 through 21. It is the first and only treatment of its kind the regulatory agency has cleared for this patient group.

News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices

This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders.

Commercial Regulation
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