Nathan Reeves

Knobbe Martens

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Latest Posts › Food and Drug Administration (FDA)

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FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more

10/12/2018 / Artificial Intelligence , Clinical Trials , Food and Drug Administration (FDA) , Innovative Technology , Medical Devices , New Guidance

Seizure-Detecting Smart Watch Given FDA Approval

The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses machine learning to monitor patients for...more

3/1/2018 / FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Smart Devices

Recall Highlights Medical Device Cybersecurity Issues

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

9/16/2017 / Cybersecurity , Food and Drug Administration (FDA) , Health Canada , Medical Devices , Patient Privacy Rights , Product Recalls

FDA to Create New Digital Health Unit

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define...more

6/21/2017 / Digital Health , Food and Drug Administration (FDA) , Medical Device User Fee Program (MDUFA IV) , Software

FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more

4/18/2016 / Food and Drug Administration (FDA) , Medical Devices , Quality Control Plan , Safety Inspections

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