Healthcare de Jure: Jason Bellet, Co-Founder and Chief Business Officer, Eko Health
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Navigating FDA Clearance for AI in Healthcare
This chapter explores the challenges of the FDA clearance process for software as a medical device, highlighting the regulatory complexities involved. It features the experiences of a pioneering company that successfully navigated these challenges by collaborating with clinical partners and emphasizing the importance of high-quality training and validation data.
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