Dexcom’s Stelo Glucose Biosensor system on Tuesday received the first FDA marketing clearance for an OTC continuous glucose monitor. Read More

On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Read More

This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic bone lesions, and a new fixation device stabilizes the sacroiliac joint without the need for lateral screws. Read More

The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following tumor removal. Read More

The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid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