Posts tagged artificial intelligence
Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.

Read More
How Artificial Intelligence is Shaping FDA’s Thinking

Recently, I had an opportunity to hear directly from FDA leaders during a fire-side chat at the Xavier Health AI Summit in Cincinnati, OH. Alonza Cruse, Director, FDA - Office of Regulatory Affairs and Bakul Patel, Associate Director, FDA – Center for Devices and Radiological Health, each shared their views on how AI is shaping FDA’s thinking in nearly all of its operations. It was very encouraging to hear that the FDA wants to build a collaborative relationship with the industry and “stand out of your way” to help realize the true potential of AI in Healthcare.  

Read More