Artificial intelligence is beginning to make its way into the world of medical device design, but Gregg Van Citters, senior consultant at Medicept, told BioWorld that there are both opportunities and tripwires on the road ahead.
Epitomee Ltd. happily swallowed the news of U.S. FDA clearance for its capsule for weight management, an ingestible medical device for adults who are overweight or obese. Designed for use along with diet and exercise, the capsule expands in the stomach to create a feeling of fullness that lasts up to six hours.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc.
The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity.
The U.S. FDA reported Sept. 17 that the Zimmer Biomet Holdings Inc. CPT hip system is associated with an increased risk of thighbone fracture, a problem Zimmer acknowledged with a July 2, 2024, class II recall.
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
The U.S. FDA approved Apple Inc.’s Airpods Pro 2 as an over-the-counter assistive hearing device for adults with mild-to-moderate hearing loss, making the ubiquitous devices the first assistive hearing technology to receive this designation.
The U.S. FDA issued warning letters to a pair of non-clinical testing labs located in China for violations of good laboratory practices, but the fall-out may reach existing marketing authorizations.
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