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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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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. But what we observed was much more complicated."

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

Medical Xpress

More information: ScienceDirect has more on ibogaine. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. All rights reserved. Your feedback is important to us.

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Dementia and high risk surgery: Joel Weissman and Samir Shah

GeriPal

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. You have a patient with dementia severe enough that she cannot recognize relatives.

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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.” . If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. Additional Links: (A to Z – under driving). OT programs). Alex: Yeah.

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Nudges for Prognosis and Comfort Care in the ICU: Kate Courtright, Scott Halpern, & Jaspal Singh

GeriPal

At one end of the spectrum you can provide decision makers with information that doesn’t work very well in most contexts. We did another nudging trial where the deep default was for default palliative care consultations for high risk patients, and it significantly increased individuals who were receiving palliative care.

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Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

The world of diets and dietary theories is complicated and can be overwhelming. However, people need to understand what works best for them individually. For healthy plate recipes or more information, please visit me at www.faithfullyrootedinhealth.com Follow me on Instagram Here ! Food has the power to regenerate the new you!