New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...

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 ...

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The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...

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 ...

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 ...