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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

When I started over 20 years ago, saw babies being born, used to do circumcisions in clinics, and then taking care of patients as they got more mature in their life, so to speak, and really loved that. I was at an ophthalmology appointment a while back and I was checking in and there was a receptionist, her name was Rosie.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Upon receiving the AI letter, appoint a lead person and disseminate the letter among team members for review. An AI letter typically begins with the most significant deficiencies.

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Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

Koblitz & Philip Won — The first anniversary is always special. Following this, in June 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) made a similar recommendation of creating a new category of OTC “wearable hearing devices.” By Jeffrey N. Gibbs & Sara W.