Regulatory

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 ...

FDA Approves Medtronic's PulseSelect™ for Atrial Fibrillation Treatment

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

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 throughout their lifecycle is of paramount importance. ...

FDA Safety Communication Does Not Impact BD Syringes

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

FDA Greenlights Medtronic's Minimally Invasive Device for Hypertension Treatment

Medtronic plc a global leader in healthcare technology, announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization....

MONARCH Platform for Bronchoscopy Receives Regulatory License for China

The MONARCH™ Platform is the first minimally invasive, robotic-assisted technology approved for bronchoscopy in a country with significant burden of lung cancer....