POC diagnostic devices developer PixCell Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its HemoScreen hematology analyzer.
The HemoScreen is a miniature portable hematology analyzer 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 Medical 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. Thus the company has named this as ‘Lab On a Cartridge.’
The HemoScreen needs no maintenance or calibration in contrast to existing solutions.
The HemoScreen can empower physicians in taking validated, data-driven decisions such as referring patients to the ER, prescribing antibiotics and other medication, ordering additional specific tests while reducing redundant tests and this can significantly improve patient care and workflow efficiency.
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.
PixCell also claims that the several clinical studies in the US and Europe in different settings such as oncology, ICU and primary care were used for validating the performance of HemoScreen.
PixCell CEO Avishay Bransky said: “We are very excited to have reached this important milestone, we have solved a decades-long problem of making a miniature POC CBC tester which is widely recognized as an unmet need.”
“The HemoScreen delivers lab accurate results and would be especially useful at physicians’ offices, ER, ICU, Oncology clinics and remote locations.”