Scopio has developed an artificial intelligence platform to automate analyzing peripheral blood smear (PBS ... Selected as one of the most innovative medical device companies "for inventing a smarter ...

In a letter to the FDA, members of Congress cite confusion over providers' deployment of clinical decision support software that is exempt from medical device regulations and call for clarity from its ...

Stern, Ariel Dora. "The Regulation of Medical AI: Policy Approaches, Data, and Innovation Incentives." Chap. 4 in The Economics of Artificial Intelligence: Health Care Challenges, edited by Ajay ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...

Algorithms that help to analyze CT scans, MRIs, and X-rays account for more than three-quarters of AI-based devices ...

By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA ...

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American ...