#353: How Artificial Intelligence is Impacting the MedTech Industry
Ashkon Rasooli, a biomedical engineer and quality management expert at Engenius Solutions, discusses the integration of AI in the MedTech industry, highlighting its statistical nature versus deterministic software. He details current applications in radiology, cardiology, and neurology, as well as wellness wearables like January AI and Whoop, while emphasizing the critical need to mitigate data bias in AI models. Rasooli also outlines a staged adoption strategy for validating AI tools within Quality Management Systems to manage inherent uncertainty, and touches on regulatory efforts by the AFDO/RAPS Working Group.