The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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 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 ...
In September 2022, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.
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 ...
BOSTON--(BUSINESS WIRE)--Etiometry, the pioneer and leader in AI-based clinical decision-support software for high-acuity units, announces the commercial release of its Algorithm Development Kit (ADK) ...
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 ...
BOSTON, May 8, 2025 /PRNewswire/ -- Glytec, the Software-as-a-Service (SaaS) technology leader and pioneer in diabetes and insulin management, today announced that their cloud-based Glucommander ...
DAYTON, Ohio--(BUSINESS WIRE)--MedsEngine announced today that Allegheny Health Network’s (AHN) Premier Medical Associates has further expanded its use of its clinical decision support software ...
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’ ...
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