JD Supra1d
Productwise Battery Shorts, Part 2: Conformity Assessment and CE Marking Requirements
In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union ...
Cadillac F1 receives approval to enter global series as expanded 11th team in 2026
Cadillac’s Formula 1 team has received official approval to join the grid in 2026 and its owners insist the team will be ...
Medical Device Network on MSN7d
Cerus secures CE mark approval for LED-based illumination device
Cerus Corporation has obtained CE mark approval for its INT200, a light-emitting diode (LED)-based illumination device, for ...
Cerus receives CE mark for next-generation INTERCEPT illumination device
Cerus (CERS) announced the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System ...
The Joplin Globe8d
Cerus Corporation Announces Receipt of CE Mark for Next-Generation INTERCEPT Illumination Device (INT200)
Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System for platelets and plasma under ...
News-Medical.Net11d
Medtronic receives FDA approval for BrainSense Adaptive DBS technology
For the one million people diagnosed with Parkinson's disease in the United States, Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug ...
Medical Device Network on MSN14d
Biomerica’s tests for IBD conditions gain CE-marking under EU’s IVDR
The IVDR certification allows the company to pursue market expansion within Europe's in vitro diagnostic market.
BioSpace16d
Nanox.ARC Imaging System Receives CE Mark, Expanding Medical Imaging Offering in European Market
CE Mark is the first major regulatory milestone for Nanox.ARC Imaging System in the European market; follows recent general use FDA clearance in the U.S. New clinical data supporting use of Nanox.ARC ...
Business Insider16d
Nano-X Imaging receives CE Mark for Nanox.ARC system
NANO-X IMAGING (NNOX) has received CE mark certification to market the multi-source Nanox.ARC system, including the Nanox.CLOUD, its accompanying cloud-based infrastructure. Nanox.ARC is a ...
Morningstar17d
Nanox.ARC Imaging System Receives CE Mark, Expanding Medical Imaging Offering in European Market
CE Mark is the first major regulatory milestone for Nanox.ARC Imaging System in the European market; follows recent general use FDA clearance in the U.S. New clinical data supporting use of Nanox ...
Medical Device Network21d
Hologic pockets CE mark for contrast biopsy software
Image credit: Frame Stock Footage via Shutterstock Hologic has obtained a CE mark in Europe for Affirm, its contrast biopsy software for use in contrast-enhanced mammography (CEM). Affirm facilitates ...
Yahoo Finance22d
Hologic Obtains CE Mark for Affirm® Contrast Biopsy Software
1-2 is now CE-marked. The technology received clearance from the U.S. Food and Drug Administration in October 2020. Designed from the ground up to integrate with the Selenia ® Dimensions ® and ...