Category: FDA Updates

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.

FDA Updates

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.

FDA Updates

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.

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

FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set

The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.

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.