PixCell Medical announces TGA approval for HemoScreen hematology analyzer

PixCell Medical, innovator of rapid diagnostic solutions at the point-of-care, has announced that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for the HemoScreen, PixCell’s hematology analyzer.

Under the TGA approval, PixCell’s HemoScreen is cleared for use with adults and infants.

The HemoScreen provides insights on 20 CBC parameters as well as comprehensive abnormal cell flagging, which can assist in the early detection of diseases, including several types of cancer. This approval confirms inclusion of HemoScreen in the Australian Register of Therapeutic Goods (ARTG), authorizing commercialization throughout Australia.

CEO Dr Avishay Bransky said: “We are delighted to receive TGA approval and are already in the process of making HemoScreen available to patients in Australia. Almost 30% of Australians live in rural areas making access to many healthcare services difficult … This technology makes the most common complete blood count (CBC) test accessible locally when results are needed quickly.”  

The HemoScreen is designed to be simple, requiring no maintenance, calibration or technical expertise. The whole CBC testing process entails three steps from sample collection to results delivery, and eliminates the manual sample preparation procedure, which can generally compromise test results. the HemoScreen provides lab-accurate results. Having blood test results on the spot allows clinicians to make decisions based on accurate data. 

A highlight of PixCell’s technology is its patented Viscoelastic Focusing (VEF) technology, which causes cells to line up in a single cell plane. This phenomenon forms the basis of PixCell’s AI-driven solution which leveraging advanced computer vision technology can rapidly analyze and differentiate cells within a sample.

The portable hematology analyzer is suitable for both human and veterinary care settings. Several government organizations in Australia have evaluated the instrument and ordered units for rapid deployment as part of their COVID-19 efforts to monitor patients.