Category: FDA Updates

FDA Updates

GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance

The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.

FDA Updates

New FDA-Approved Therapy Brings At-Home Electrical Field Treatment to Pancreatic Cancer Care

The wearable system uses alternating electrical fields to disrupt cancer cell division and can be used continuously during daily activities.

FDA Updates

FDA Clears Elekta’s AI-Powered CT-Linear Accelerator

Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.

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

FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices

Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.

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.