Remove Clinic Remove Electronics Remove Engineering Remove Individual
article thumbnail

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

FDA Law Blog

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.

Clinic 105
article thumbnail

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. Couldn’t imagine doing anything else.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

FDA Law Blog

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.

article thumbnail

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

Medical Xpress

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).

article thumbnail

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. Your feedback is important to us.

Provider 109
article thumbnail

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.” . I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Additional Links: (A to Z – under driving). OT programs). Alex: Yeah.

Families 102
article thumbnail

Dementia and high risk surgery: Joel Weissman and Samir Shah

GeriPal

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. Samir: Thanks, Alex and Eric.