BOENNIGHEIM, Germany and LIGONIER, Ind., Nov. 4, 2025 /PRNewswire/ -- Hohenstein Medical – a division of Hohenstein Laboratories and a leading provider of testing, research and certification services ...
Healthcare resilience goals and regulatory frameworks accelerate adoption of AI-enabled medical technology solutions, ISG Provider Lens ® report says LONDON--(BUSINESS WIRE)-- European medical device ...
LONDON--(BUSINESS WIRE)-- European medical device companies are carrying out digital transformations to modernize regulatory operations, strengthen post-market surveillance and improve patient safety, ...
Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
LONDON–(BUSINESS WIRE)–$III #AI–European medical device companies are carrying out digital transformations to modernize regulatory operations, strengthen post ...
SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- Alife Health, a health tech company advancing the future of fertility care with artificial intelligence, today announced that Embryo Predict™, its ...
objectiveFIELD is the first and only truly objective perimeter FDA 510(k) cleared to assess visual field abnormalities. IRVINE, CA, UNITED STATES, October 10, 2025 ...
The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
The European Union's Medical Device Regulation (MDR 2017/745) has fundamentally reshaped the path to market for medtech innovators. While designed to enhance patient safety, the MDR has introduced a ...