The FDA recently issued draft guidances ... finding applications across medical devices and pharmaceutical development. In medical devices, AI models power tools such as software that analyzes ...

Professionals enrolled in the certificate will develop an understanding of critical regulatory, economic, and legal issues in addition to the project management skills that facilitate the development ...

AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

Specifically, when it comes to its goal of balancing reasonable regulation with the development ... process of approving new medical devices to running three-year backlogs, the FDA is failing ...

The FDA is ramping up efforts to address medical device shortages that are increasingly threatening patient care, particularly for pediatric and neonatal populations. In a Jan. 16 news release ...

Development and Documentation "The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...

A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...

But the nature of the development process typical for such devices suggests many ... resulting in an FDA Class II recall as well as an ICS Medical Advisory from CISA.” That 2023 RCE ...