Category: FDA Updates

FDA Updates

FDA Clears Medtronic Surgical System for Cranial and ENT Procedures

The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.

FDA Updates

FDA Clears GE HealthCare’s MIM LesionID Pro for Automated Tumor Burden Analysis

The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.

FDA Updates

FDA Clears Medtronic Robotic Spine Surgery System

The system brings surgical planning, real-time navigation, and robotic capabilities together in a single platform designed for spine procedures

Clearances

FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.

Recalls

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.

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.