Global/International

Neuspera Medical’s Battery-Free Neuromodulation System Shows Promising Results in UUI Clinical Trial

Six-month study demonstrates 85% symptom reduction and strong safety profile, advancing a minimally invasive solution for urgency urinary incontinence treatment. ...

Sway Medical Secures FDA 510(k) Clearance for Concussion Management System Expanding Digital Health in the U.S.

The mobile-based solution enhances concussion assessment and monitoring with real-time, objective data for sports, military, and clinical applications across the United States....

OrthoNovis Secures FDA Clearance for BPS Wrist Fracture System

The 510(k) clearance enables OrthoNovis to enter the U.S. orthopedic fracture fixation market with its innovative locking wrist plates, advancing treatment options for distal radius fractures and fusions. ...

Averto Medical’s ColoSeal™ Wins FDA Breakthrough Device Designation for Colorectal Surgery

Minimally invasive ICD system aims to eliminate temporary ostomies, improving recovery and quality of life for patients undergoing colorectal surgery....

Medtronic Secures FDA Approval for BrainSense™ Adaptive DBS, Pioneering Largest BCI-Enabled Therapy Launch

New real-time, self-adjusting deep brain stimulation system transforms Parkinson’s care with personalized neuromodulation...

Immunovia to Appoint New CFO as Company Shifts Focus to U.S. Market

With plans to commercialize its pancreatic cancer test in the U.S. by late 2025, Immunovia seeks financial leadership with diagnostics expertise and global capital market experience....

Co-Diagnostics Withdraws 510(k) Submission for COVID-19 Test to Pursue Enhanced Version

Following constructive discussions with the FDA, Co-Dx shifts focus to an improved test submission, incorporating platform advancements and optimizing long-term performance....

UroMems Achieves Major Milestone in First-Ever Smart Implant Study for Female SUI Patientsv

With all female patients in its groundbreaking clinical feasibility study reaching six-month primary endpoints, UroMems' UroActive System marks a transformative step in treating stress urinary incontinence. The AI-powered smart implant, designed to enhance patient quality of life, is now paving the way for expanded adoption in the U.S. and Europe. ...

CathVision Secures CE Mark for ECGenius System, Expanding Electrophysiology Innovation Across Europe

With CE Mark certification, the AI-powered ECGenius System is now approved for commercialization in the European Economic Area, enhancing real-time electrogram recording and clinical decision-making for healthcare providers....