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 [...]
UroMems Receives Clearance from the FDA and the French ANSM for Initiating Landmark Pivotal Clinical Study of UroActiveÒ Smart Implant to Treat Male Stress Urinary Incontinence
IDE approval in both countries follows strong feasibility clinical results [...]
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
With this clearance, Maestro Systems can now have active Wi-Fi [...]
Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
Exo Iris® now automatically detects and localizes key pulmonary findings [...]
Expanding Innovations Receives FDA Clearance for N-GAGE™ Lumbar Plate System
The modular, low-profile construct offers spine surgeons a flexible fixation [...]
TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
A flowable bio-gel to protect healing tissue and preserve function.
FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System
Reflow Medical, Inc., a leading developer of innovative medical devices [...]