Category: FDA Updates

FDA Updates

FDA Clears Wireless Maternal-Fetal Monitoring Platform

The wearable sensor system provides continuous, simultaneous monitoring of maternal and fetal vital signs to improve clinical evaluation.

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.

Clearances

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.

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.