Tue.Sep 03, 2024

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Where Have All the De Novo Summaries Gone: An Update

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos. We are happy to report that fifteen new decision summaries have been posted as of August 28. Notably, two decision summaries were posted for De Novos that had been granted in 2020 and two were posted for De Novos granted this year.

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A Friend Like That

Evergreen Family Medicine

My younger sister, Esther, underwent coronary artery bypass surgery this August. It should have been me. Esther weighs about 110 pounds, runs 4-6 miles daily, plays tennis, eats a healthy, mostly plant-based diet, doesn’t smoke or drink alcohol, and has no adverse health conditions. Her angiogram showed severe and diffuse multivessel disease.Two years apart, Esther and I have always been close, as we navigated life together.

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Episode 352 – RLR – The Wrong Context

The Clinical Problem Solvers

[link] Title – The Wrong Context Episode description Reza and Rabih discuss a fascinating case of jaundice Student discount [link] IMG discount Use coupon code RLRIMG at check out [link]

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