Category: FDA Updates

FDA Updates

FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths

The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.

FDA Updates

FDA Clears New Contrast-Enhanced Breast Imaging Capabilities for Mammomat B.brilliant

The newly cleared contrast-enhanced mammography and biopsy capabilities aim to help radiologists characterize suspicious findings and perform targeted biopsies more efficiently.

FDA Updates

Philips Adds AI Measurement and Lesion Classification Tools to Ultrasound Systems

The FDA-cleared update automates measurement tasks and provides clinical decision support to improve imaging workflow.

Clearances

FDA OKs AI Early Warning System for Hospital Sepsis Detection

The technology, developed by Johns Hopkins University researchers, identifies sepsis cases up to 48 hours earlier than traditional methods and has reduced mortality rates by 18%.

Recalls

FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

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.