The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

With the Food and Drug Administration adopting a limited role in regulating software that assists physicians with clinical decisions, a coalition of providers and developers released voluntary ...

The 21st Century Cures Act amended section 520 of the Federal Food, Drug & Cosmetic Act to exclude certain medical software functions, including certain decision support software, from the definition ...

Findings indicate that such software can dramatically improve patient safety during surgery. A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General ...

A coalition of organizations interested in making or using clinical decision support software has finalized voluntary guidelines aimed at self-regulating new technology that uses data and machine ...

The U.S. Food and Drug Administration's latest plan for overseeing clinical decision-support software leaves too much room for interpretation over what types of software the agency intends to regulate ...

The American Medical Informatics Association said recent guidance from the U.S. Food and Drug Administration for clinical and patient decision support tools is "well-timed to initiate a broad ...

FDA's second attempt at a regulatory approach to clinical decision support software appears to be better received by the medical device industry, which lauded the agency for taking a risk-based ...

BOSTON--(BUSINESS WIRE)--Etiometry, a leader in clinical decision-support software for critical care, announced today that the company has obtained the CE Mark under the European Union's medical ...

The Class I recall of McKesson's Anesthesia Care software provides clues as to what FDA considers to be high-risk clinical decision-support software and high-risk bugs. By Bradley Merrill Thompson On ...