In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical ...

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its final guidance, “Clinical Decision Support Software,” representing a shift from what was proposed in the 2019 draft guidance.

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 ...

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 ...

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 ...

InsightRX today announced the company's AI precision dosing software is now deployed across more than 1,000 hospitals , marking the largest expansion of clinical decision support.

BOSTON--(BUSINESS WIRE)--Etiometry, the leader in clinical decision-support software for critical care, today announced it has received its 6th 510(k) clearance from the US Food and Drug ...

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The American Hospital Association released a statement expressing concerns about the FDA’s draft guidance expanding its oversight of clinical decision support software under the 21st Century Cures Act ...

Sioux Falls, S.D.-based Avera Health plans to implement clinical decision support software at birthing units systemwide, software developer PeriGen confirmed July 10. The labor analysis software, ...

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 ...

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 ...