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.

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

The clearances include one for an AI-assisted quality control software that detects six common whole-slide image artifacts.

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

According to CEO Wesley Sukdao, Proteotype is also gearing up to raise about £5 million and seeking a lead investor.

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

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

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

The technology supports the adoption of digital pathology and artificial intelligence in cancer diagnostics by enabling greater consistency in laboratory slide staining.