TaeWoong Medical USA Receives FDA 510(k) Clearance for SPAXUS™, Expanding Its EUS Therapeutic Portfolio
The FDA determined the SPAXUS Stent to be substantially equivalent [...]
Grifols Gets FDA Approval for Malaria Blood Screening Assay
The Procleix Plasmodium Assay aims to improve blood safety by [...]
Cala Wins FDA Clearance for New TAPS Wearable for Tremor and Parkinson’s
The Cala kIQ Plus provides new therapy modes and adaptive [...]
SwiftMR® by AIRS Medical Gains FDA Clearance for Use with OEM Deep Learning MRI Solutions
SwiftMR®, is an FDA 510(k)-cleared, vendor-neutral MRI image enhancement solution [...]
Restore Robotics Receives FDA 510(k) Clearance for 2 Additional da Vinci Xi® Robotic Instruments
With these latest clearances, Restore Robotics continues to deliver on [...]
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
First and only FDA-approved therapy for the treatment of acquired [...]
Centauri Therapeutics granted FDA QIDP status for CTX-187 treatment of Gram-negative bacterial infections
Dr. Debra Barker, Chief Medical Officer, Centauri Therapeutics, said: “This [...]
Airiver Medical Granted FDA’s Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial
Designation may provide U.S. patients faster access to groundbreaking technology [...]
Expanded FDA 510(k) Clearance Supercharges Bayer’s MEDRAD® MRXperion System for Broader MR Deployment
Clearance reinforces Bayer’s continued commitment to dependable, integrated radiology solutions [...]
Synergy Spine Solutions Earns FDA Approval for the Synergy Disc, Advancing Cervical Disc Replacement in the U.S.
Milestone approval advances a new category of artificial cervical disc [...]