Stakeholders suggested that while the FDA rule is dead, updates to LDT regulation are coming, nonetheless, and the industry ...

The development marks a shift up the value chain for labs and could prove a meaningful revenue stream for providers able to ...

China's volume-based procurement policy and US tariffs have forced companies with large businesses in China to reset their ...

Danaher subsidiaries Beckman Coulter, Cepheid, and Leica Biosystems will be working together with external partners to focus ...

Some experts believe a technological tipping point is imminent, if not already here, but adoption of point-of-care MDx has ...

Developed as part of a broader collaboration between the two firms, the tool uses generative AI to let providers ask questions and describe conditions in plain language.

Through clinical trials, partnerships, and economic studies, a crop of test developers is trying to prove the value of their ...

The laboratory medicine organization is focused on the benefits of using data science within laboratories to more effectively care for patients and track utilization.

Cemhan Biricik, CEO of Fast Lab Technologies, and Martin Perlin, its medical director, are alleged to have billed public and private payors for testing that was never done.

An assessment of the documentation for 30 over-the-counter diagnostic tests found none met the current regulatory standards.

The company's platform combines microfluidics, cytology, and artificial intelligence-based image analysis for the identification of mild-to-severe dysplasia.

The firm cited supply chain adaptation as one of the keys to reducing tariff impacts but declined to provide granular details.