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August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Deciding whether to purchase or lease laboratory instrumentation involves a variety of factors.
Release of second-generation Cologuard test data and recently announced partnerships aim to position company well for the future.
Diagnostics companies that invested heavily in COVID-19 products are relying on M&A transactions to restructure and transition.
In the first half of this year, US companies have cut the second-highest total of jobs since 2009, according to a recent report.
A recent SCOTUS ruling on a healthcare fraud case could help defend labs against baseless whistleblower cases.
Labs will have to submit Z-Codes with every molecular pathology testing code billed to UnitedHealthcare, starting Aug. 1.
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
A new five-metabolite blood test designed by algorithm could simplify and speed up this challenging diagnosis.
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.