North America

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....

Ginkgo Bioworks Secures €24M EU Grant to Develop Rapid Next-Gen Sequencing for Respiratory Diagnostics

In collaboration with HaDEA and HERA, Ginkgo leads the RANGER project to create a point-of-care metagenomic sequencing device, aiming for 6-hour turnaround diagnostics to revolutionize pandemic preparedness and hospital triage across Europe. ...

SurgiBox Secures Two U.S. Patents to Advance Mobile Surgery Innovation

Cambridge-based medical device startup SurgiBox Inc. receives utility and design patents for its SurgiField™ technology, enhancing mobile surgical capabilities with advanced airflow and smart control innovations....

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. ...