Article Name Regulatory

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....Read more

06th February, 2024


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 ...Read more

05th February, 2024 | By Ankit Kankar | ankit.kankar@mmactiv.com 


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 ...Read more

26th January, 2024


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...Read more

24th January, 2024 | By Vrushti Kothari 


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...Read more

17th January, 2024 | By Vrushti Kothari 


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...Read more

12th January, 2024 | By Vrushti Kothari 


Lucem Health Launches Reveal for Faster AFib-Related Stroke Treatment

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

18th December, 2023


FDA Approves Medtronic's PulseSelect™ for Atrial Fibrillation Treatment

Safe, efficient, and effective treatment for both paroxysmal and persistent atrial fibrillation...Read more

14th December, 2023


Postmarket Surveillance of Medical Devices: Ensuring Safety and Efficacy

Medical devices play a crucial role in modern healthcare, ranging from simple tools like thermometers to complex devices such as pacemakers and imaging equipment. Ensuring the safety and efficacy of these devices through...Read more

11th December, 2023


FDA Safety Communication Does Not Impact BD Syringes

Company Committed to Support U.S. Health Care Needs...Read more

04th December, 2023


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