FDA Clears Hybrid Heart Imaging System
The platform combines ultrasound and optical imaging to provide detailed views of coronary anatomy in a single workflow.
Category: FDA Updates
FDA Updates
Latest
FDA Updates
Latest
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
Latest
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.
Clearances
Latest
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
Recalls
Latest
GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
Labeling
Latest
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
Latest
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.