North America

Nanodropper Wins 2nd Place at K-Startup Grand Challenge 2024 in South Korea

The US-based healthcare startup is recognized for its groundbreaking innovation in optimizing eyedrop medication, improving affordability, and enhancing patient adherence....

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. ...

Addiction Prevention Coalition and DisposeRx Expand Opioid Education and Disposal Efforts in Alabama

The initiative strengthens opioid prevention across Alabama by providing communities with vital education and at-home medication disposal solutions to reduce misuse and accidental overdoses....

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...

Sonar Mental Health Secures $2.4M Pre-Seed Funding to Expand AI-Powered Mental Health Support Across U.S. Schools

With backing from Nina Capital, GSR Ventures, and J4 Ventures, Sonar aims to scale its AI-driven Wellbeing Companion, Sonny, to more school districts across California, Texas, Illinois, Michigan, and Arkansas, addressing the growing adolescent mental health crisis. ...

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....