Tag: FDA approval
FDA Grants Medtronic Breakthrough Device Designation for Transcatheter Valve System
The FDA Breakthrough Devices Program enables manufacturers to streamline the market clearance/approval process for specific medical devices. Medtronic received the breakthrough device designation for ... Read More
FDA Stance on 3D Printing During COVID-19 Pandemic
In an update Thursday, the FDA clarified its stance on 3D-printing medical devices, and accessories amid the COVID-19 pandemic. As American COVID-19 infection rates skyrocket and surpass the number of... Read More
Aerin Medical Wins FDA Approval for Nonsurgical Chronic Rhinitis Procedure
Aerin Medical Wins FDA Approval for Nonsurgical Chronic Rhinitis Procedure Aerin Medical, a company that develops in minimally invasive, nonsurgical treatments for chronic nasal airway conditions, ann... Read More
NeuroPace RNS System Received FDA Approval for MRI Labeling
NeuroPace RNS System for Epilepsy Received FDA Approval for MRI LabelingNeuroPace announced that its RNS® System has received FDA approval for MRI labeling, increasing number treatment options for ap... Read More
Medicrea’s Patient-matched Interbody Cages FDA Approved
Medicrea’s Patient-matched Interbody Cages FDA ApprovedMedicrea has announced FDA clearance for their UNiD® IB3D Patient-Matched interbody cages which will be added to their UNiD® Adaptiv... Read More
FDA Approves AI Software to Capture Heart Images Via Ultrasound
The FDA has announced approval and authorization of Caption Health‘s AI software, Caption Guidance, to analyze and assist with cardiac ultrasounds (echocardiography). Heart disease kills approxi... Read More
