Category: FDA Updates

FDA Updates

FDA Clears New Device for Transseptal Heart Access

The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.

FDA Updates

MARS Bioimaging Gains FDA Clearance for Portable Photon-Counting CT Scanner

The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.

FDA Updates

Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

Clearances

FDA Clears Elekta’s AI-Powered CT-Linear Accelerator

Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.

Recalls

GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals

The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.