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

FDA Law

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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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

However, we do not guarantee individual replies due to the high volume of messages. Your feedback is important to us. E-mail the story Texas invests $50M in psychedelic drug research to treat addiction Your friends email Your email I would like to subscribe to Science X Newsletter.

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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

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. We tested two different nudges individually and then we combined them. I highly encourage you. Kate 13:59 What did we do?