Category: FDA Updates

FDA Updates

FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery

The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.

FDA Updates

FDA Clears Mobile C-Arm System With AI-Enhanced Imaging

The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.

FDA Updates

Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking

The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.

Clearances

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.

Recalls

Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue

The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.

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.