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Emerging From the Pandemic: CDRH In-Person Meeting Status and Premarket Workload

CDRH is pleased to announce that we have been operating under normal review timelines for all incoming premarket submissions for almost a year, and we’re accepting all submission types for review.

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Elon Musk's Neuralink Receives FDA Approval To Begin Clinical Trials For Brain Implants

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Elon Musk's Neuralink receives FDA approval to begin clinical trials for brain implants

Elon Musk's Neuralink has received approval from the Food and Drug Administration (FDA) to begin clinical trials for its brain implants. According to Ars Technica's John Timmer, Musk [...]

Owen-faris , Elon-musk , John-timmer , Drug-administration , National-institutes-of-health , Reuters , Office-of-product-evaluation , Natural-news , Ars-technica , South-african-born , Product-evaluation , National-institutes

Lawmakers press FDA on clinical trial holds

Top House lawmakers wrote to the director of the FDA Center for Biologics Evaluation and Review, asking why the agency so frequently issues clinical trial holds to experimental cell and gene therapies.

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Colorectal Cancer: What You Should Know About Screening

Doctors recommend most people start screening for colorectal cancer at age 45, and before age 45 for some people at higher risk. There are several FDA-reviewed and approved or cleared choices for colorectal cancer screening. Find out which one is best for you.

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FDA rejects Elon Musk's bid to test Neuralink brain implants in humans

The Food and Drug Administration (FDA) has rejected Elon Musk's application to conduct human trials of his Neuralink brain implant device over safety concerns. Seven current and former [...]

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US regulators rejected Elon Musk's bid to test brain chips in humans, citing safety risks

On at least four occasions since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness. Yet the company, founded in 2016, didn't seek permission from the US Food and Drug Administration (FDA) until early 2022 — and the agency...

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U.S. regulators rejected Elon Musk's bid to test brain chips in humans, citing safety risks

BRAIN initiative team leader Nick Langhals said the agency reached out to Neuralink to offer help but was declined. 

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Why US regulators rejected Elon Musk's bid to test brain chips in humans

A year after the rejection, Neuralink is still working through the agency's concerns

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Life Science Partner recruits Oracle Health Leader to advance FDA's Digital Health Division and Center of Excellence

/PRNewswire/ -- Life Science Partner announces the recruitment of the FDA's new Division Director for Digital Health and Director for the Digital Health Center...

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