The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
The med-tech financing landscape in 2024 has shown remarkable improvement over last year, with $4.62 billion raised in the initial two months, an increase of 176.62% from the $1.67 billion raised during the same period in 2023.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquedeon, Biotronik, Conavi Medical, Edan Instruments, Global Health Labs, Grail, Natera, Onward Medical, Polarisar, Titan Medical.
Medical Korea 2024 opened to a large audience in Seoul, South Korea for a two-day run to highlight advances in the medical field, including those in radiotherapy.
Sooma Oy recently raised €5 million (US$5.4 million) in funding to help the company expand access to its transcranial direct current stimulation device which allows patients to treat their depression at home. “This is a significant milestone for us that enables us to help more patients globally and help us develop the company to serve the unmet need,” Tuomas Neuvonen, Sooma's co-founder and CEO, told BioWorld.
The U.S. Environmental Protection Agency (EPA) has issued its long-awaited final rule governing emissions of ethylene oxide (EtO), a rule announced by the agency with the concurrence of Xavier Becerra, the Secretary of Health and Human Services. However, the final rule provoked an immediate response from Sen. Bill Cassidy (R-La.), who said the final rule will “put American lives in danger.”
There are coincidences and then there are big coincidences, the latter of which might describe a new U.S. FDA draft guidance and a major cybersecurity breach. The agency has issued a draft update to its premarket cybersecurity guidance even as the Department of Health and Human Services announced an investigation into the hack of the IT system at Change Healthcare, a pair of developments that seem likely to set the world of connected medical devices on its collective ear.
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