Pixcell Medical gets FDA Clearance for Portable Hematology Analyzer

PixCell Medical received the US Food and Drug Administration (FDA) 510(k) clearance for its HemoScreen hematology analyzer

The HemoScreen is a miniature portable device that utilizes disposable cartridges. Each of the cartridges includes all the required reagents and is designed to accept a drop of blood taken from the finger.

PixCell claims that the device can operated with minimal training or expertise. Once the cartridge is inserted into the reader, the blood sample will be processed automatically and analyzed within the cartridge. The company named this as ‘Lab On a Cartridge.’

The HemoScreen uses a technology based on microfluidics, machine vision and artificial intelligence (AI).

By using a new concept of Imaging Flow Cytometry, cells are flow focused into a single layer plane within a microfluidic chamber and their images are analyzed on the fly. This method is claimed to provide highly repeatable and accurate analysis arising from flow and high resolution and sensitivity attained by imaging.

The HemoScreen delivers lab accurate results and would be especially useful at physicians’ offices, ER, ICU, Oncology clinics and remote locations.

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