The U.S. FDA has categorized a recall of Abbot pacemakers caused by a manufacturing process that allowed moisture into the devices as a Class I event; some devices containing the fault could still be in use, reports MedTech Dive.
TruAsset has implemented direct communications between its CMMS software and Fluke Biomedical OneQA workflow automation software to streamline preventive maintenance for HTM professionals.
If independent servicers were so unskilled and unsafe to use, manufacturers wouldn’t so heavily rely on them, asserts IAMERS General Counsel Robert Kerwin in his opinion piece in the Wall Street Journal responding to another recent op-ed.
Computer scientists at the University of California San Diego have developed a more accurate navigation system that will allow robots to better negotiate busy clinical environments in general and emergency departments more specifically.
Global safety science company UL has received designation as an accredited ISO/IEC 17025 laboratory under the U.S. FDA Accreditation Scheme for Conformity Assessment, a voluntary pilot program for medical device safety and performance testing.
LG Business Solutions USA announces the latest in LG’s line of professional, medical-grade diagnostic monitors, the 31-inch, 12-megapixel 31HN713D, which can be used for multiple modes of diagnostic study, including 3D mammography.
AAMI’s updated HTM Levels Guide is now available with an online assessment tool, enabling healthcare technology management departments to measure themselves against a national benchmark of excellence.
The technology collaboration will ease insulin management for people with diabetes and their healthcare providers in markets outside the United States.
The report’s findings, including that “there is scant evidence to support manufacturers’ justifications for repair restrictions,” are primarily based on responses to the FTC’s requests for public comments and empirical research issued in connection with its July 2019 workshop, “Nixing the Fix: A Workshop on Repair Restrictions.”