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

Permanente Medicine

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

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

FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments. in-the-know/our-specials":{"type":"Static","pageId":"u7hat"},"./schedule":{"type":"Static","pageId":"tg6i2"},"./medspa":{"type":"Static","pageId":"hr7g7"},"./meet-the-team":{"type":"Static","pageId":"w0jmf"},".

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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.