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https://www.medtechdive.com/news/bd-fda-warning-letter-pyxis-safety/736124/ BD receives FDA warning letter over quality system violations | MedTech Dive Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD... fda warning letter quality system medtech dive bd receives https://www.medtechdive.com/news/whoop-fda-warning-letter-blood-pressure-wellness/753489/ Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric | MedTech Dive Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a... fda warning letter sparks debate blood pressure medtech dive wellness https://www.medtechdive.com/news/medline-recalls-angiographic-syringes-receives-fda-warning-letter/817433/ Medline recalls angiographic syringes, receives FDA warning letter | MedTech Dive The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds. fda warning letter medtech dive medline recalls syringes https://www.morganlewis.com/blogs/asprescribed/2026/04/fdas-warning-letter-suggests-growing-scrutiny-of-ai-overreliance FDA AI Compliance: Warning Letter Signals New Scrutiny of AI Use FDA’s warning letter shows expanding scrutiny of artificial intelligence use in regulated operations, emphasizing that companies remain responsible for... ai compliance warning letter signals new fda scrutiny https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-clinic-illegally-marketing-unapproved-thermography-device-warns-consumers FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns... FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast... fda issues warning letter clinic illegally marketing