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Apple has filed a lawsuit against Delaware-based medical device developer Masimo, alleging that the company infringed upon numerous Apple Watch patents with its new W1 smartwatch line. Read More
An FDA advisory panel has voted 11-2 against approval of SOLVD Health’s De Novo request to market AvertD, a genotype test to identify patients at increased risk of opioid use disorder (OUD). Read More
The FDA’s biggest challenge in protecting medical devices from cybersecurity breaches is legacy technology, says a top agency technology official. Read More