Health Canada Licenses Point-of-Care Hematology Analyzer for Decentralized CBC Testing

PixCell Medical’s HemoScreen point‑of‑care hematology analyzer received a Health Canada Class III Medical Device License and will be distributed nationwide through Inter Medico. The authorization follows the company’s recent Medical Device Single Audit Program (MDSAP) certification and is intended to support adoption of near‑patient complete blood count (CBC) testing across multiple care settings. The distribution partnership provides a local channel to introduce the system broadly to laboratories and healthcare providers throughout the country.

Canada’s vast geography creates distinct challenges for delivering timely diagnostic services across widely dispersed communities, especially with nearly one in five Canadians living in rural areas. As a result, demand for decentralized diagnostics is driving interest in near-patient workflows that reduce dependence on centralized laboratories and support faster clinical decision-making. As demand grows for decentralized testing, HemoScreen provides a near-patient approach to hematology diagnostics.

Image: PixCell Medical’s HemoScreen POC hematology analyzer combines AI-powered digital imaging with Viscoelastic Focusing technology to deliver lab-quality 5-part differential CBC results (Photo courtesy of PixCell Medical)

HemoScreen uses a fully self‑contained, disposable cartridge that requires only a drop of venous or capillary blood. The analyzer combines AI‑powered digital imaging with proprietary Viscoelastic Focusing technology to deliver lab‑quality, 5‑part differential CBC results without maintenance, calibration, external reagents, or liquid waste. The platform is positioned for use in hospitals, community clinics, oncology centers, and remote healthcare settings where conventional laboratory analyzers may be impractical.

The Health Canada license and the Inter Medico partnership establish the foundation for commercial expansion in Canada. Inter Medico, which has introduced advanced diagnostics to Canadian laboratories for more than 45 years, brings nationwide account management, field service, and technical support capabilities. 

“We want to ensure that all laboratories and healthcare providers, including those in small rural and remote locations, have access to the technology and information they need to best care for their patients. We have partnered with PixCell Medical because we've seen how HemoScreen has improved patient care in hospitals and laboratories in other countries and we've seen firsthand how easy it is to implement and use,” said Dan Lichtman, CEO of Inter Medico.

“Receiving Health Canada's authorization marks an exciting milestone for PixCell Medical as we continue expanding access to rapid, decentralized hematology testing around the world. Canada's healthcare system includes many hospitals and communities where timely access to lab diagnostics can make a meaningful difference to patient care. Together with Inter Medico, we look forward to making lab-quality CBC testing more accessible wherever clinical decisions are made,” said Dr. Avishay Bransky, CEO and co‑founder of PixCell Medical.

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