Category: FDA Updates

FDA Updates

Nova Biomedical Pulls StatStrip Gen 2.0 Glucose Meters Over Patient ID Errors

A software issue can cause glucose results to be assigned to the wrong patient's medical record. One serious injury has been reported, and a fix is expected in November.

FDA Updates

BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy

The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.

FDA Updates

FDA Seeks Input on Generative AI Medical Device Regulation

The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem.

Clearances

FDA Clears PACS Viewer for Integrated EHR Imaging Workflows

The diagnostic imaging viewer enables clinicians to access and process medical images directly within the company's electronic health record platform, eliminating the need to switch between separate imaging and clinical systems.

Recalls

FDA Recall Issued for Ivenix Infusion Pump Software Due to Shutdown Risk

The company is advising users to keep devices plugged into AC power following a software anomaly that may cause false battery readings and unexpected shutdowns.

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.