Category: FDA Updates

FDA Updates

Fresenius Kabi Removes Ivenix Large-Volume Pumps

A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.

FDA Updates

FDA to Accept De-identified Data for Certain Medical Devices Submissions

New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.

FDA Updates

FDA Clears AI Tool for Coronary Plaque Analysis

The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.

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

Tandem Issues Correction for t:slim X2 Insulin Pumps

A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.

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.