Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the...
FDA Clears Profound Medical’s AI Model for Treating Prostate Cancer
Profound Medical (Nasdaq: PROF) has received FDA 510(k) clearance for its second AI model aimed at treating prostate cancer. Profound Medical is a Toronto-based company, which specializes in developing and...
Orthobond Received FDA De Novo Approval for Antibacterial Technology
Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating. Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial, polycationic molecules to...
FDA Approves Edwards EVOQUE® Tricuspid Valve Replacement System
The U.S. Food and Drug Administration (“FDA”) recently approved the Edwards EVOQUE® Tricuspid Valve Replacement System (the “EVOQUE® system”) for use in treating Tricuspid Regurgitation (“TR”). The EVOQUE® system is...
FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System
The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement. The shoulder includes the glenohumeral joint, which is the ball-and-socket joint where...
FDA Publishes New Monkeypox and Medical Devices Web Page
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs),...
Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic...
