{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"MedTech Speed to Data","title":"Startup Advice for AI Enabled Products : 40","html":"","width":"100%","height":180,"duration":2387,"description":"Hundreds of approved devices use artificial intelligence to help physicians diagnose patients faster and more accurately. Brooke & Associates is a legal and regulatory advisory firm that helps medical device makers get AI-powered devices through FDA pre-market approval.In Episode #40 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers and Lei Zong speak with the firm’s managing member, Jason Brooke, about the FDA’s latest guidance to medical device developers for integrating AI into their products.Need to knowAI’s role in MedTech — AI identifies otherwise undetectable data patterns that humans can apply in clinically meaningful ways.FDA’s AI staffing surges — The agency accelerated hiring to develop internal AI applications and support pre-market reviews of new AI-powered devices.Radiological imaging leads the pack — More than half of 900+ FDA-approved AI-based products are in radiological imaging.Other fields are catching up — Cardiology and neurology applications are more recent entrants in AI-powered devices, but their numbers are growing.The nitty-grittyThe FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” in early 2025 to explain how it will address AI’s adaptive nature in medical device regulation.“This guidance is really focused on a total product lifecycle approach,” Brooke explains.Good management practices govern traditional medical device development, so documenting the development process in pre-market submissions is not as critical. AI model development is different because the model can evolve once in service.“There’s a level of information that’s necessary in submissions for AI-based technologies that we haven’t had to provide to the FDA before,” Brooke says. “They want a lot of information,” Brooke says. “That’s an area I think may be problematic because a lot of that is somewhat trade secret.”AI-specific guidance touches almost every aspect of a...","thumbnail_url":"https://img.transistorcdn.com/D6hMCysuuZpZO9MQfRbgtr2o9UZ_Mtc0h1qVAxU8GII/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS83MGQ2/N2MwMDdmNTRmOTRl/M2Y0MTcyNjAwN2Mz/OWRlZi5qcGc.webp","thumbnail_width":300,"thumbnail_height":300}