Category: FDA Updates

FDA Updates

FDA Clears Silicon Photonics System for Lung Biopsy Procedures

The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.

FDA Updates

BD Advises Biomed Inspection of Dropped Alaris Pump Modules

The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.

FDA Updates

Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk

The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.

Clearances

FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound

The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.

Recalls

Class I Recall Expanded for Alaris Pump Infusion Sets

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

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.