There was a noticeable uptick in digital pathology devices and software clearances among more than a dozen 510(k)s granted by the agency last month.

NEW YORK – Proteotype Diagnostics is barreling toward the clinical market with a new study planned for Enlighten, its multicancer early detection test, while another study is set to commence that will ...

NEW YORK – Danaher subsidiary Leica Biosystems announced on Tuesday that the US Food and Drug Administration has granted and expanded 510(k) clearance for three of its digital pathology solutions, ...

LisenID uses a biomarker called loss of imprinting to apply to ambiguous biopsy results and return a diagnosis of lung cancer.

Natera's tissue-free assay Latitude will be used in Kupando's clinical trial of its lead immunotherapy candidate KUP-101.

An analyst with investment bank Leerink partners noted that Freenome is addressing a significant total addressable market in liquid biopsy cancer screening.

The company also submitted a request for a CLIA waiver for the test, which would permit its use in decentralized testing locations.

Recent catalysts such as an FDA approval, NCCN guideline inclusion, and Japanese regulatory approval have fueled the firm's goals to expand its presence.

The clearance also includes a predetermined change control plan to lower regulatory hurdles around changes to the software's use.