The point-of-care CBC platform enters the Canadian market following Health Canada Class III licensing and a distribution agreement with Inter Medico.
PixCell Medical announced its expansion into the Canadian market following the receipt of a Health Canada Class III Medical Device License for its HemoScreen point-of-care hematology analyzer, according to a company press release.
The regulatory clearance, which builds on the company’s Medical Device Single Audit Program certification, is paired with a commercial distribution agreement with Canadian diagnostic distributor Inter Medico. The collaboration aims to expand access to decentralized Complete Blood Count (CBC) testing across hospitals, community clinics, oncology centers, and remote care facilities throughout Canada.
Point-of-Care Hematology Testing
Canada faces distinct logistical challenges in delivering timely diagnostic services across geographically dispersed communities, with nearly one in five Canadians living in rural areas, according to PixCell Medical.
The HemoScreen platform is designed to provide five-part differential CBC testing closer to the patient using a single drop of venous or capillary blood. The analyzer combines artificial intelligence-driven digital imaging with proprietary Viscoelastic Focusing technology within a self-contained, disposable cartridge. According to the company, the system requires no routine maintenance, calibration, external reagents, or liquid waste management, enabling hematology testing in settings where conventional laboratory analyzers are impractical.
“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,” says Dan Lichtman, CEO of Inter Medico, in a release. “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.”
Nationwide Distribution Agreement
Under the partnership, Inter Medico will manage distribution and support services for the analyzer across Canadian healthcare networks. Inter Medico has supplied diagnostic instrumentation and reagents to Canadian laboratories and healthcare providers for more than 45 years, according to the release.
“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,” says Dr Avishay Bransky, CEO and co-founder of PixCell Medical, in a release. “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.”
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