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 ...
The U.S. Food and Drug Administration plans to issue guidance explaining how it intends to regulate artificial intelligence and clinical decision support technologies in early 2018 under the 21st ...
JUPITER, Fla. & VANCOUVER, British Columbia, November 03, 2025--DoseMe, a global leader in model-informed precision dosing (MIPD) software and a portfolio company of Fairlong Capital, today announced ...
The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...
UpToDate—the popular clinical research and information database used by thousands of hospitals around the globe—has officially tacked on an AI solution. As one family physician put it, who currently ...
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 U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this ...
Unfortunately, in developing its new approach to regulating clinical decision support (CDS) software, FDA has chosen to ignore that basic principle as well as a promise the agency made to Congress and ...
Dr. Eve Cunningham is group vice president and chief of virtual care and digital health at health system Providence and founder of MedPearl. And Providence is getting ready to spin off MedPearl.
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’ ...
In this special guest feature, Bradley Merrill Thompson, a partner in the Washington DC office of law firm Epstein Becker & Green and Chairman of the Board of the firm’s consulting affiliate EBG ...
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