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The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted. Read More
Companies seeking approval for medical devices that contain AI are still asked to jump through the basic regulatory hoops inherent in trying to bring any new device to market — but now the FDA is increasing its expertise in AI and asking for more data. Read More
This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Read More
Using the app for two four-hour periods of sleep during the same 10-day period should provide enough data for users to have an informed conversation with a healthcare provider. Read More
This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal cord injury patients. But in a refreshing win for actual humans, a large study finds that the surgeon’s hands are just as good as robotic techniques in arthroscopic knee repair. Read More
Despite FDA skepticism, the agency’s Circulatory System Devices Panel advisory committee endorsed Abbott’s TriClip, a transcatheter edge-to-edge repair system intended to treat tricuspid regurgitation. Read More