NEW YORK – C2N Diagnostics said Thursday that its PrecivityAD2 Alzheimer's test has received 510(k) clearance from the US Food and Drug Administration. The mass spectrometry-based blood test is ...
NEW YORK – Avricore Health subsidiary HealthTab announced on Thursday that it has signed an agreement with Abbott to supply and distribute the firm's point-of-care testing products in the UK.
The firm recently raised $15 million in seed financing to further validate and commercialize its pathogen detection and antimicrobial resistance profiling platform.
NEW YORK – AmoyDx announced on Monday that it has received approval from Japan's Ministry of Health, Labour and Welfare for the AmoyDx Pan Lung Cancer PCR Panel as a companion diagnostic for Nippon ...
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.
Analysts for the banks noted the large addressable market for the company's cancer screening tests as well as the benefits of its commercialization deals with Abbott and Roche.
The clearances include one for an AI-assisted quality control software that detects six common whole-slide image artifacts.
Recent catalysts such as an FDA approval, NCCN guideline inclusion, and Japanese regulatory approval have fueled the firm's goals to expand its presence.
Natera's tissue-free assay Latitude will be used in Kupando's clinical trial of its lead immunotherapy candidate KUP-101.
LisenID uses a biomarker called loss of imprinting to apply to ambiguous biopsy results and return a diagnosis of lung cancer.
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