News

Metal AM magazine6d
EOS Medical Device Master File helps accelerate regulatory approvals for AM manufacturers
EOS GmbH, headquartered in Krailling, Germany, has announced its latest advancement in regulatory compliance support for ...
Medical Design & Outsourcing2d
Six tips for using customer visits to better understand device user needs for new product development
Avoid common pitfalls and transform your customer visits into powerful catalysts for user-inspired device design and ...
Petros Pharmaceuticals Strengthens Partnership with Market Leading Big Data Provider Implementing Key Enhancements to its AI Platform
Company continues to innovate and develop its SaaS-based platform to facilitate Rx-to-OTC switch in line with recent President Trump Executive Order NEW YORK, NY / ACCESS Newswire / May 6, 2025 / ...
STAT3dOpinion
A court decision on lab-developed tests sets a dangerous precedent
An under-the-radar court ruling may be among the most significant harbingers of the crises to come for the FDA and public ...
FDA approves SAPIEN 3 platform for asymptomatic severe aortic stenosis
The U.S. Food and Drug Administration has approved Edwards Lifesciences' SAPIEN 3 platform, a transcatheter aortic valve ...
Modern Healthcare5d
GE HealthCare's AI tool for MRI images cleared by FDA
GE HealthCare also said it will be adding Spectronic Medical AB’s MRI Planner software to its radiation oncology portfolio.
STAT6d
EHR companies push deregulation. Microsoft exec pushes back
I flagged a proposal for “ Smart Deregulation ” by the EHRA, which represents medical record software companies like Epic Systems and Oracle Health . The organization basically wants the federal ...
Medical Device Network on MSN1d
BrightHeart gains new clearance for heart defect detection platform
The BrightHeart platform enables clinicians to view real-time analysis of foetal congenital heart defects directly on a ...
Medical Device Network6d
Neuralink wins FDA breakthrough tag for speech restoration
The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation for the treatment ... playing video games and started to use 3D design ...