FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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The Medical Futurist

JUNE 21, 2025

Running trials in animals will take additional engineering and safety tests. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. Harbisson received a specialised electronic eye, his “eyeborg” to be able to render perceived colours as sounds on the musical scale.

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Diabetes Patient-Centered IT Patients 105

Permanente Medicine

MAY 20, 2025

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. Couldn’t imagine doing anything else.

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Patient-Centered Patients IT Medical 52

FDA Law Blog

JULY 10, 2023

When a firm submits a Traditional 510(k), FDA first performs the acceptance review to determine whether a submission is administratively complete, or passes the technical screening for an electronic submission submitted using the eSTAR. An AI letter typically begins with the most significant deficiencies.

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

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Provider Medical Complication Diabetes 109

GeriPal

JUNE 15, 2023

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. Because I think in the near future they will be able to take audio recordings and conversations and make clinical notes that then the clinician can edit. This is Eric Widera. Welcome to the GeriPal podcast, Charlotta. Charlotta: Thank you.

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IT Patient-Centered Patients Healthcare 99