North America

Covenant High Plains Performs First Robotic Pelvic Organ Prolapse Surgery

First independent ambulatory surgery center in the region to perform advanced minimally invasive urological procedure using the Da Vinci X robot...

Medcrypt Unveils FDA Cybersecurity Readiness Services for Med Device Firms

With Medcrypt's FDA Cybersecurity Readiness Services, MDMs can confidently navigate mandatory eSTAR for 510(k) submissions and the FDA's upcoming Cybersecurity Refuse To Accept Policy for other submission types, benefiting from a mock submission process with expert feedback and review....

Atlanta's First BioMech Clinical Motion Lab Utilizes AI-driven Motion Science for Trauma Recovery at Clinic and Home

BioMech, Atlanta's Independent Neurodiagnostic Clinic join forces to help patients and health care providers quantitatively measure and monitor function...

RIVANNA Secures $30.5M from BARDA to Advance Accuro XV Musculoskeletal Imaging

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software....

Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support crit...

Alma Veil™ Launched in the U.S. Market by Sisram Medical's Alma

Alma, a global leader in the energy-based medical and aesthetic solutions industry, proudly announces the commercial availability of Alma Veil™. This advanced, dual-wavelength vascular laser workstation establishes a new standard in excellence by optimizing efficiency with remarkable efficacy across a comprehensive range of vascular and dermatological conditions....

BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States....

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Initial clinical study results will inform pivotal clinical trial in U.S. and Europe...

Verantos' AI Advancement in Neurology Bolstered by Groundbreaking Migraine Real-World Evidence

Technology enables inference of subjective outcomes from routinely collected data...

Hackensack Meridian JFK University Medical Center Performs First Robotic Surgery with Heated Chemotherapy for Malignant Thymoma

Surgeons in the Division of Thoracic Surgery at JFK University Medical Center first in the State of New Jersey to perform this surgery...