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  • The clinical laboratory industry praised the legislation, which also calls on the National Academy of Medicine to make recommendations on how to improve the data collection process.


    In the Journal of the American Heart Association, researchers examined long-term data pooled from the Protect AF and Prevail clinical trials of the company's Watchman device for stroke prevention in atrial fibrillation patients.

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    The Health Information Technology Research and Development Interagency Working Group will seek feedback from industry, academia and government experts on potential solutions for creating interoperable systems.

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  • Memorial Sloan Kettering's breast imaging chief said a notification of higher risk may be "unduly alarming" to patients if providers aren't required to offer additional context and resources.

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  • The new regulations will force hospitals to report incidents within 30 days.

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    The medical device industry is lobbying Capitol Hill and statehouses, warning limited access to the sterilant could pose deadly disruptions.

  • The text hews closely to the draft the agency issued in 2017, the core of which detailed its policy on 510(k) filings.

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  • The company expected to complete key studies around the middle of 2019 and bring the test to market by year's end, but has now abandoned the target.

  • The benign prostatic hyperplasia update will provide 32 million people insured by Anthem access to the implant.

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    The document addresses clinical studies for general surgical tools for prostate tissue ablation, differentiating them from technologies treating specific diseases like prostate cancer or benign prostatic hyperplasia.