Digital health executive Acacia Parks, Ph.D. lays out five trends in digital therapeutics (DTx) for the new year.
Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be ...
Where is the best place to locate manufacturing to minimize supply chain risk, maintain a low cost of goods sold, and ...
In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software ...
To gain U.S. Food and Drug Administration (FDA) approval and be first to market in the United States, a startup with a novel Class III mitral valve repair therapy needed to first fine-tune some of the ...
While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances ...
FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 ...
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