FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests

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  Lab and Pathology Insider Logo  
March 12, 2019  
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FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
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placeholder PRECISION MEDICINE
Donor-Derived, Cell-Free DNA May Predict Lung Transplant Rejection
From - Diagnostic Testing & Emerging Technologies
Elevated donor-derived, cell-free DNA (ddcfDNA) in the 3 months post-lung transplant can identify clinically silent allograft injury and…
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The Dx Pipeline: A Roundup of the Month's Key New Product Launches
From - Laboratory Industry Report
After a slow January, new product development picked up steam in February. Here's a rundown of the key new launches…
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placeholder OIG OPINION
Is Your Billing Company Putting You At Compliance Risk?
From - Lab Compliance Advisor
Does your orthopedic billing company charge a percentage of collections for their coding and billing…
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