Reuters7h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics ... according to data from the National ...
News Medical7h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
Hosted on MSN8h
Abbott's Freestyle Libre CGMs Cleared for Use During Imaging Tests
But now, Abbott’s FreeStyle Libre 2 and 3 have received the first and only FDA clearance that allows patients to keep ...
JD Supra10h
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
MassDevice13h
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
MassDevice14h
GE HealthCare wins FDA nod for new head-only MRI system
GE HealthCare says the head-only design allows the system to deliver a gradient amplitude and slew rate far surpassing those ...
Business Insider15h
GE HealthCare's Head-Only MRI System Gets FDA Clearance
(RTTNews) - GE HealthCare Technologies Inc. (GEHC) Wednesday said that it has received FDA 510(k) clearance for its innovative ... Madison and Brigham and Women's Hospital. For More Such Health News, ...
Morningstar15h
GE HealthCare Gets FDA Approval For Head-Only MRI Scanner
The Chicago-based medical technology company said the MRI device, called Signa Magnus, had received 510(k) clearance by the U.S. Food and Drug Administration. That approval pathway is for devices that ...