These DIY kits are a $5 billion industry. We report on the pros, the cons, and the ones to avoid at all costs.

HueDx, Inc. has unveiled groundbreaking research showing the effectiveness of its HueTools and HueLab, a smartphone-enabled, ...

A family-owned independent Pennsylvania laboratory has been ordered to pay $7.3 million dollars to the New Jersey Medicaid ...

Cytovale has developed a FDA-cleared, rapid diagnostic tool for sepsis, and it just raised $100 million to roll it out to ...

Accelerate Diagnostics, Inc. AXDX has secured FDA 510(k) clearance for its Accelerate Arc system and BC kit, designed for use ...

Proteotype Diagnostics, a cancer detection startup based in Cambridge, is planning staged global growth in terms of headcount ...

On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical ...

The company aims to streamline its own lab operations while also enabling distribution of its Alzheimer's tests to outside ...

Cleared by the FDA in 2022, the approach literally squeezes white blood cells for information on the state of the body’s ...

In addition to distributing Gradientech's QuickMIC system in the US and Canada, Hardy Diagnostics will become one of the firm's largest shareholders.

Magellan Diagnostics is sentenced to pay over $40 million for concealing defects in their lead testing devices.