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

FDA Law

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
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How Your Emotional Health Impacts Blood Pressure

Imperial Center Family Medicine

It’s similar to revving a car engine for too long while staying still. Studies associate the two hours after an episode of rage with a higher risk of adverse cardiovascular events. People with clinical depression often have elevated cortisol levels, potentially leading to high blood pressure over time.

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

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Bathrooms “R” Us

Physician's Practice

This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage. This article inspired by Shep Hyken’s article appearing in Forbes Magazine Neil Baum, MD , a Professor of Clinical Urology at Tulane University in New Orleans, LA.

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

IT 102
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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. Patients nowadays have evolved, so our ability to build and engineer AI systems to help people help themselves is going to be the future.

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Dementia and high risk surgery: Joel Weissman and Samir Shah

GeriPal

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. Eric: Let’s say tomorrow, a patient comes into your clinic. Eric: Mm-hmm. Eric: How about you, Samir? Eric: So Samir, you’re a surgeon, right?