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 ...

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 ...

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 ...

BOSTON--(BUSINESS WIRE)--Etiometry, a leader in clinical decision-support software for the intensive care environment, today, announced significant business growth and expansion in 2020. Clinicians in ...

The CDS Coalition is asking the U.S. Food and Drug Administration to pull back on its clinical decision support guidance in order to ensure that the agency better balances its regulatory oversight ...

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 ...

The Blueprint for an AI Bill of Rights the White House recently published didn’t come a moment too soon for the health care industry. Most of the AI-driven applications in health care are known as ...

A new study by investigators from Massachusetts General Hospital, a founding member of the Mass General Brigham healthcare system, reveals that computer software that helps inform clinicians’ ...