Category: FDA Updates

FDA Updates

Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments

Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.

FDA Updates

GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer

The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.

FDA Updates

FDA Clears Cardiovascular Monitoring Software for Surgical and ICU Settings

Argos Infinity analyzes existing physiologic data streams to provide early detection of hemodynamic instability without requiring new bedside hardware.

Clearances

FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System

The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.

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.