North America

Seonix Bio Launches SightScore™, the First Clinical PRS Test for Glaucoma in the U.S.

Early glaucoma detection, SightScore™ empowers eye care professionals with advanced genetic insights to identify high-risk individuals before symptoms appear, paving the way for proactive vision care....

Sebelas Miudella™ Becomes First FDA-Approved Hormone-Free IUD in 40 Years

Offering a long-acting, non-hormonal birth control option, the approval marks a significant milestone in expanding contraceptive choices for individuals seeking hormone-free alternatives. ...

Arcuro Medical Secures FDA 510(k) Clearance for SuperBall-RC™ Rotator Cuff Repair System

New device simplifies graft fixation, enhancing rotator cuff repair outcomes with a planned launch in 2025....

USA’s Identiv and Novanta Partner to Advance RFID Solutions for Medical Device OEMs

Collaboration integrates Identiv’s RFID inlays with Novanta’s reader technology to enhance traceability, patient safety, and smart medical device performance....

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....