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 [...]
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 [...]