U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
Paige PanCancer Detect recognized by FDA as a Breakthrough Device [...]
restor3d Receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System
This milestone marks a significant achievement in expanding restor3d’s knee [...]
Phantom Neuro Receives FDA Breakthrough Device & TAP Designations, Solidifying Position as a Neurotech Leader
“Receiving both of these certified designations from the FDA is [...]
FDA Approves LANCELOT Technology for Corcym’s Perceval Plus, Enhancing Performance of Sutureless Aortic Valve Replacement
Lancelot Technology: CORCYM , the medical device company dedicated to [...]
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 [...]