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 ...

FDA recently released six software-related guidances, advancing the agency’s Digital Health Innovation Action Plan: 1 “Clinical Decision Support Software” 2 (revised Draft Guidance issued for comments ...

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its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.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 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 ...

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the Mayo Clinic, Regeneron and others are seeking more clarity from the US Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software.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 ...

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 ...

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’ ...

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 ...