A fully implantable, titanium total artificial heart (TAH) from Bivacor of Huntington Beach, CA, has received Breakthrough Device Designation from FDA as a bridge to transplant (BTT) for adults with ...

One medical device company is going against the trend of shedding a spine unit in favor of focusing on stronger parts of the business. Highridge Medical (a spin-off spine business of ZimVie) has ...

Less than eight months after getting FDA's blessing to bring its Versius surgical robotic system to the U.S. market, Cambridge, England-based CMR Surgical is reportedly seeking a buyer. The Financial ...

Medtronic is making a slight change in its policy for hybrid workers. The Dublin-based company is now increasing in-office work requirements to at least four days a week, according to a report from ...

Boston Scientific is discontinuing sales of its Acurate neo2 and Acurate Prime transcatheter aortic valve replacement systems. The Marlborough, MA-based company added that it would not pursue ...

On Jan. 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...

In this webinar, you’ll learn about six top trends — and what’s behind them — from a panel of experts in the neurotechnology space, each with decades of experience in creating wearable neurotech ...

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture.

Ensuring accuracy by force measurement and material testing is a necessary requirement in most every industry, especially orthopaedic and medical parts manufacturing where the highest quality control ...

Encapsulating an Active Implantable Medical Device (AIMD) is a critical and often challenging step. AIMDs are subject to some of the most stringent quality requirements and standards in order to ...

Amanda Pedersen poses with her Jesse H. Neal Awards plaque after winning the "Best Commentary" category with Pedersen's POV After 18 years of reporting on the medical device and diagnostics industry, ...

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture.