NEW YORK (360Dx) – PixCell Medical announced today that the US Food and Drug Administration has cleared its HemoScreen Hematology Analyzer for marketing in the US.
The miniature, portable hematology analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood from the finger. The cartridge is inserted into the reader, and the blood sample is automatically processed and analyzed within the cartridge. The HemoScreen, PixCell said, requires no maintenance or calibration, making it easy to use in physician offices, the ER, ICU, oncology clinics, and remote locations.
The analyzer leverages microfluidic technology, as well as machine vision, artificial intelligence, and a concept the Israeli firm calls imaging flow cytometry. Cells are flow-focused into a single layer plane within a microfluidic chamber and their images are analyzed on the fly. The method enables high reproducibility and accuracy from flow and high resolution and sensitivity attained by imaging.
The analyzer has been validated in clinical studies in the US and Europe in settings such as oncology, ICU, and primary care, PixCell added. Future assays based on the same technology platform will detect life-threatening diseases such as cancer, infections, and heart failure.
HemoScreen was CE marked several years ago, but PixCell's CEO said in March that the firm had not commercialized it because the company lacked the ability to produce a large amount of cartridges and wasn't ready to deploy the device.