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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.

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    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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  • 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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    Ear, nose and throat therapies company Intersect has hired Thomas West, who spent 22 years in various Johnson & Johnson positions, to increase sales of its sinus implants.

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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.

  • 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.