Regulatory

Elevating Culture: Olympus Unveils New Core Values Aligned to Global MedTech Leadership

Forging a Path to Excellence: Olympus' New Core Values Propel MedTech Leadership Worldwide...

The Department of Health – Abu Dhabi inks strategic partnership with Masdar City, Xlife Sciences, and Thermo Fisher Scientific

Collaborative Milestones: Department of Health – Abu Dhabi Teams Up with Masdar City, Xlife Sciences, and Thermo Fisher Scientific...

JIVA.AI Teams Up with Aevice Health for Innovative Asthma AI with FDA-Cleared Remote Patient Monitor

Jiva.ai and Aevice Health collaborate to pioneer breakthrough medical AI for asthma adverse event prediction based on Aevice Health’s FDA-cleared remote patient monitor....

MicroPort EverPace's Columbus™ 3D EP Navigation System Receives CE MDR Certification

MicroPort EverPace's latest generation Columbus™ 3D EP Navigation System (Columbus™) has recently received CE MDR approval....

FDA Reveals Revolutionary Overhaul of Quality Management System Regulations for Medical Devices in Pursuit of Global Harmonization

In a significant stride towards harmonization with international standards, the U.S. Food and Drug Administration (FDA) announced the issuance of a final rule amending the Quality System (QS) Regulation, titled "Quality Management System Regulation (QMSR)," on January 31, 2024. ...

Enhatch Receives FDA Clearance for AI-Enhanced TKA Instrumentation System

Enhatch Inc. is excited to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance of a patient specific instrumentation system for Total Knee Arthroplasty. This state-of-the-art system is redefining total knee arthroplasty with its AI-driven approach, encompassing both anatomic model generation and treatment planning...

Olympus Closes the Acquisition of Korean Gastrointestinal Stent Company, Taewoong Medical Co., Ltd

Olympus Strengthens its Medical Portfolio with Successful Acquisition of Taewoong Medical Co., Ltd, a Leading Korean Gastrointestinal Stent Company...

Aya Healthcare Expands into UK with ID Medical Acquisition

Aya Healthcare's Global Expansion: ID Medical Acquisition Marks Strategic Entry into the UK Healthcare Market...

3M receives $34.2 million award to improve treatment of traumatic wounds from point-of-injury to hospital

Advancing Trauma Care: 3M Secures $34.2 Million Grant to Enhance Treatment of Traumatic Wounds Throughout the Entire Healthcare Journey...

Lucem Health Launches Reveal for Faster AFib-Related Stroke Treatment

Groundbreaking Solution Identifies Undiagnosed AFib and Speeds Treatments Proven to Prevent Strokes ...