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its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.
A new study by investigators from Massachusetts General Hospital reveals that computer software that helps inform clinicians' decisions about a patient's care can prevent 95% of medication errors in ...
Industry groups, the Mayo Clinic, Regeneron and others are seeking more clarity from the US Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software. The ...
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 ...
FDA updated two key digital health guidance documents to align with the Administration’s emphasis on deregulation and innovation in health care technology, including the use of generative AI. The ...
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 ...
OXFORD, England--(BUSINESS WIRE)--Optellum, a lung health company aiming to redefine early diagnosis and treatment of lung disease, today announced it received FDA 510(k) clearance for its Virtual ...
Cancer Informatics for Cancer Centers: Scientific Drivers for Informatics, Data Science, and Care in Pediatric, Adolescent, and Young Adult Cancer Informatics solutions to early diagnosis of cancer in ...
At the end of a long week filled with too many deadlines and too little sleep, you wake up one morning woozy with a strange pain in your arm. You call your doctor, and she asks you a series of ...
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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