FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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An Automated Assist in Revenue Cycle Management
How automation, artificial intelligence, and other emerging technologies are elevating the efficiency and output of labs’ revenue cycles
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Digital Pathology and AI: Now and in 2025
Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold
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Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
From – Laboratory Industry Report
Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath’s Oncotype DX, which is now covered by most of …
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FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From – Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
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LDTs: Top 10 New FDA Diagnostic Approvals of 2017
From – Laboratory Industry Report
The phrase “most exciting FDA laboratory developed test approvals of the year” is no longer an oxymoron. The agency remains glacial in tempo…
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Industry Buzz: 2017-The Year in DX Mergers & Acquisitions
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CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval
From – Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
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CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
By Kyle Fetter bio
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA process was…
Outreach Labs Remain Profitable Despite Antiquated Systems & Lack of Exec Respect
From – Laboratory Industry Report
Hidden within the basement of your average hospital is a $24 million business, one that provides a top quality, must-have service and operates at a margin of…
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FDA Watch: New Moves to Boost CLIA Transparency
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Industry Trends: New Report Sheds Light on DX Tech Capital Flows
From – Laboratory Industry Report
The health care industry has raised $5 billion in venture fund investment in the first half of 2017 and is well on pace to smash the single year record of…
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