FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
TNKase is delivered as a single five-second intravenous (IV) bolus, [...]
Co-Diagnostics Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
The decision by Co-Diagnostics to withdraw the submission was based [...]
U.S. FDA Grants Orphan Drug Designation to Ariceum Therapeutics’ Proprietary Radiopharmaceutical Cancer Therapy
Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: “Receiving [...]
Huxley Medical’s SANSA Home Sleep Apnea Test Gets FDA Nod
In a clinical trial involving 340 patients across seven institutions, [...]
RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™
RapidAI continues to pioneer AI advances by revolutionizing 3D imaging [...]
Caranx Medical Announces FDA Submission of TAVIPILOT Soft: the World’s first AI Software for Real-time Intra-operative Guidance of Transcatheter Heart Valve Implantation
“This first release of our TAVIPILOT software marks an important [...]
Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery
“Receiving Fast Track designation from the FDA reinforces the potential [...]
FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
Christopher M. Owens, President and Chief Executive Officer of R3 [...]
Exactech Reports the FDA Clearance of Truliant® Porous 3D Tibial Implant for Knee Replacement Surgery
The Truliant Porous Tibial Tray leverages additive manufacturing technology to [...]
GT Metabolic Solutions Announces FDA Clearance of their GT Metabolic’s MagDI™ System
With this FDA clearance, the MagDI System is poised to [...]