Research & Development
PixCell Medical announces FDA 510(k) clearance for HemoScreen Hematology Analyzer
7 November 2018 -

POC diagnostic device company PixCell Medical disclosed on Wednesday that its HemoScreen Hematology Analyzer will be commercialised in the US, following FDA 510(k).

PixCell Medical said the HemoScreen is a miniature portable hematology analyzer. It has a disposable cartridge that includes all necessary reagents and is designed to accept a drop of blood taken from the finger. When the cartridge is inserted into the reader, the blood sample is automatically processed and analyzed within the cartridge, a concept termed by the company as "Lab On a Cartridge".

The company added that HemoScreen requires no maintenance or calibration and is expected to enable physicians to make validated, data-driven decisions: referring patients to the ER, prescribing antibiotics and other medication and ordering additional specific tests, while reducing redundant tests.

According to PixCell Medical, the performance of the HemoScreen has been validated in several clinical studies in the USA and Europe, in various settings such as oncology, ICU and primary care. The hematology analyzer uses patented technology based on microfluidics, machine vision and artificial intelligence (AI). It utilises a new concept: Imaging Flow Cytometry where cells are flow focused into a single layer plane within a microfluidic chamber.



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