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 [...]
Medtronic receives FDA clearance for Stealth AXiS™ surgical system | 1st Integrated planning, navigation and robotics platform for spine surgery
The Stealth AXiS system is cleared for spine procedures in [...]
Proprio Reports: 4th FDA Clearance Highlights Growing Shift to 3D Measurement in Spine Care
Picasso Experience Expands Surgeon-Controlled, Radiation-Free Registration Workflows for Real-Time Intraoperative [...]
FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen DeficiencyFDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency
The 2-gram single-dose bottle joins the existing 1-gram version, giving [...]
W&H Medical Unveils the Only FDA-Cleared Piezo & Drill Combo Console for Rhinoplasty and Facial Surgery
Showcasing at Bringing You The Masters with Dr. Aaron Kosins [...]
Terumo Interventional Systems Announces Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receive FDA 510(k) Clearance
OPUSWAVE Imaging System combines OFDI and IVUS into a single [...]
FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy’s Disease
“Receiving the Fast Track Designation for AJ201 marks a significant [...]