Devices

124 Novel Medical Devices Authorized in 2025: Report

The CDRH 2025 Annual Report says the Center authorized 124 novel medical devices last year, including the first blood test to diagnose Alzheimer’s disease. The report says the number of authorizations was one of the highest in the Center’s more than 40-year history.

Other accomplishments cited by CDRH director Michelle Tarver included strengthening safety and quality through initiatives like the Early Alert Program, convening a Digital Health Advisory Committee, announcing the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices pilot, and opening MDUFA 6 negotiations.

The report says CDRH was on track in 2025 to meet all of its MDUFA 5 metrics.

A page highlighting the Center’s impact in 2025 cites 264,070 devices regulated, 21,780 medical device submissions received, 25,530 registered medical device manufacturing firms, 10 actions to reduce regulatory burden, 21 guidances issued, and 125 safety-related communications.

Looking ahead, CDRH says that in 2026 it will (1) implement the new Quality Management System regulation; (2) promote artificial intelligence, digital health, and next generation technologies; (3) expand postmarket safety efforts, sustain premarket momentum, and optimize compliance activities; and (4) strengthen CDRH resilience to adapt to staffing changes, evolving processes, and shifting technological demands.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome