Roche announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S.

SAN DIEGO--(BUSINESS WIRE)--XiFin, Inc., a leading provider of innovative healthcare information technologies and services that deliver artificial intelligence (AI)-enabled operational efficiency, ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic (Nasdaq: HOLX) announced today that it has completed regulatory filings needed to make Panther Trax ® available in a number of countries and regions.

When extracts of a medical device are required for a biocompatibility test protocol, a current practice is to follow the guidance in ISO 10993 Biological evaluation of medical devices–Part 12: Sample ...