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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

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

Permanente Medicine

Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. It’s around providing the best value. million members and patients.

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

FDA Law Blog

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied.

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright.

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . That’s where it really gets to this individual risks and balances, individual situation. There is a dearth of Certified Driving Rehab Specialists: 12 for the entire state of Colorado!

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Improving Nursing Home Quality: Jasmine Travers, Alice Bonner, Isaac Longobardi, and Mike Wasserman

GeriPal

Summary Transcript Summary In April 2022, the National Academies of Sciences, Engineering and Medicine (NASEM) issued a report on how the United States delivers, regulates, finances, and measures the quality of nursing home care. Mike: Electronic record keeping, Eric, is the government’s gift to defense attorneys.

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