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FDA Medical Device Ban Overturned For the First Time

FDA Law Blog

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.

Medical 52
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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Because how that is approached can have lasting effects on relationships, unfortunately. Or have electronic health record prompts so people remember to ask it? I think I’m really drawn to hard conversations.

IT 102
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Time for Geriatric Assessments in Cancer Care: William Dale, Mazie Tsang, and John Simmons

GeriPal

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? ” And we can by targeting these supportive care interventions.

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Pragmatic Trial of ACP: Jennifer Wolff, Sydney Dy, Danny Scerpella, and Jasmine Santoyo-Olsson

GeriPal

So we have to collect what information we have available from Health Information exchange and electronic health records. Sydney 21:41 So we did find increased documentation of the primary outcome in the electronic health records. Sydney 22:01 Well, it’s what’s in the electronic health record. Eric 22:03 Okay.