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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

Each of these De Novos can represent a clinical advance. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. De Novos now play an important role in product advancement. For example, FDA granted seven De Novos for COVID-19 related indications for use.

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Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

When was that, 2010? Eric: 2010. I think … There’s so few, seriously, from the hospital system and the pathologizing systems to the more social care intervention work that Susan and I really do. There’s a whole age-friendly hospital systems that we are supposed to start our journey and keep going.

Community 101
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Palliative care for cancer: Podcast with Jennifer Temel and Areej El-Jawahri

GeriPal

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. Jennifer: It was 2010. Eric: 2010. Jennifer: They have a meaningful impact on what happens to them during the hospitalization and after. Jennifer: Thanks.

Illness 110
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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers. And then the second one in 2015.

IT 99
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Understanding the Variability in Care of Nursing Home Residents with Advanced Dementia

GeriPal

On today’s podcast we dive into drivers of invasive procedures and hospitalizations in advanced dementia by talking to some pretty brilliant nursing and nurse practitioner researchers focused on dementia, geriatrics, and palliative care in nursing homes: Ruth Palan Lopez, Caroline Stephens, Joan Carpenter, and Lauren Hunt. Rehabbed to Death.

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Podcast: Cervical Spine Injuries & Imaging in Children

PEMBlog

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Epub 2010 Oct 29. If they have no pain in the midline with any of these movements, then the cervical spine is clinically cleared.