NEW YORK – Sera Prognostics on Thursday afternoon reported a 45 percent year-over-year decline in third quarter revenues. For the quarter ended Sept. 30, the Salt Lake City-based maternal and neonatal ...

Given the amount of tests that have required certification under the new system, the EU has staggered the grace periods for different classes of devices already holding CE-IVD marks obtained under the ...

Labcorp will acquire outreach labs serving patients in Indiana and northwest Ohio while Parkview will continue to operate labs serving acute and emergency needs.

The updated CE marking now enables labs in Europe to unify their workflows for both cell and tissue slide imaging and processing.

NEW YORK – Precision oncology firm Personalis announced on Monday that its NeXT Personal test for minimal residual disease has received coverage from the US Centers for Medicare and Medicaid Services ...

Last week, readers were most interested in a story about how Siemens Healthineers is preparing for possible changes by its parent firm.

Designed for routine clinical use, the system can identify M-proteins based on their molecular weight to help diagnose multiple myeloma and related disorders.

Legislation passed by the US Senate to reopen the federal government includes a temporary delay to price cuts and data reporting requirements.

The company said that recent study results show its Aventa Lymphoma test can provide actionable information that would typically be missed by FISH testing.