Nasdaq

GE HealthCare achieves MRI portfolio milestone with FDA clearances for next-generation SIGNA MRI technology designed to enhance precision imaging and clinical efficiency

SIGNA Sprint with Freelium, a new 1.5T sealed magnet MRI system, combines a sustainable design with uncompromised image quality, and operational autonomy to expand access to advanced MR, even in ...
Business Wire

Ezra Receives 510(k) FDA Clearance For AI That Enhances MRI, Enabling Fast, Low-Cost Scans

NEW YORK--(BUSINESS WIRE)--Ezra, the healthcare AI startup transforming early cancer detection through full body MRI screening, announced today that its newest proprietary Artificial Intelligence, ...
Morning Overview on MSN

The FDA approved a lower-dose contrast agent to cut patients’ exposure during MRI scans

Patients who need repeated MRI scans with contrast dye could soon receive a fraction of the gadolinium they currently get.
Nasdaq

ClearPoint Neuro Announces FDA Clearance Expanding Compatibility of the ClearPoint Prism Neuro Laser Therapy System with 1.5T MRI Scanners

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise ...
RAPS

FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification ...
Morningstar

GE HealthCare Announces First Patient Dosed in Phase 2/3 LUMINA Trial for Manganese-Based MRI Contrast Agent Under FDA Fast Track Designation, Further Advancing Its Innovation ...

Mangaciclanol, if approved, could transform contrast-enhanced MR imaging by offering an alternative to - or even replacing - gadolinium-based MRI agents A manganese-based MRI contrast agent could ...