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 [...]
Thirona Receives FDA Clearance for LungQ® 4 Software, Expanding AI-Powered Capabilities in Lung Image Analysis for the U.S. Market
This new clearance builds on version 3 of LungQ®, cleared [...]
Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance
“This clearance classifies the system under product codes QFF and [...]
NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain
The study is designed to compare genicular artery embolization (GAE) [...]
Medicus Pharma Ltd. Receives Positive Feedback From the FDA Type C Meeting Supporting the Development of Skinject
The FDA agrees that the Company may follow 505(b)(2) regulatory [...]
Medtronic secures FDA approval for the Altaviva™ device, a simple experience for treating urge urinary incontinence
“The Altaviva device represents a significant advancement for patients with [...]
Myra Vision Secures FDA Approval to Initiate US IDE Study in Glaucoma
The ADAPT study will evaluate the safety and effectiveness of [...]
SurGenTec® Achieves Key Milestone with Expanded Indications for OsteoFlo® HydroFiber™
This expansion of indications now includes use as a bone [...]