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EndoStim has received the FDA’s Breakthrough Device designation for its EndoStim System for treatment of patients with gastroesophageal reflux disease (GERD) who do not respond to drug therapy. Read More
The FDA’s General and Plastic Surgery Devices Panel met on Wednesday and Thursday to consider the agency’s proposed classifications of seven types of devices, voting in all cases to support its recommendations. Read More
The FDA aims to help industry prepare responses to deficiency letters by suggesting a standardized format, the agency said in a final guidance released yesterday. Read More
The FDA has requested that Accelerate Diagnostics discontinue marketing and distribution of its Accelerate Arc system and related blood culture kit as they are not Class I devices and therefore not exempt from 510(k) clearance. Read More
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
The FDA’s biggest challenge in protecting medical devices from cybersecurity breaches is legacy technology, says a top agency technology official. Read More