Yokneam Illit, Israel, September 2, 2026
PixCell Medical has expanded its international presence into Canada through a strategic partnership with Inter Medico, following Health Canada Class III medical-device licensing for the company’s HemoScreen™ hematology analyzer. The regulatory milestone enables HemoScreen to enter the Canadian market as PixCell Medical continues to expand access to rapid, decentralized blood testing technologies. The partnership combines PixCell Medical’s microfluidic hematology technology with Inter Medico’s established Canadian distribution and diagnostics infrastructure, supporting commercialization and availability of the system across healthcare settings. HemoScreen is designed to provide rapid complete blood count (CBC) testing from a small whole-blood sample, potentially supporting faster clinical decision-making in emergency departments, outpatient clinics, physician offices and other decentralized care environments. The Canadian market entry represents another step in the international adoption of PixCell Medical’s point-of-care hematology platform.
Health Canada Grants Class III Licence for HemoScreen
The Health Canada Class III licence is a significant regulatory milestone for HemoScreen because Class III devices are subject to higher levels of regulatory scrutiny than lower-risk medical devices. The authorization allows PixCell Medical to commercialize the HemoScreen system in Canada for its intended diagnostic use. The system uses PixCell Medical’s proprietary Viscoelastic Focusing (VEF™) technology, a microfluidic approach developed to analyze blood cells using a compact testing platform. The technology enables automated hematology analysis from a small blood sample, reducing the need for conventional laboratory infrastructure while supporting rapid turnaround. HemoScreen is designed to deliver a five-part differential complete blood count, providing measurements of key blood-cell parameters including white blood cells, red blood cells, hemoglobin, hematocrit and platelets. The analyzer requires only a small sample of whole blood and is intended to generate results within minutes. This combination of automated testing, small sample volume and rapid analysis is particularly relevant to point-of-care and decentralized diagnostic environments, where access to full-scale laboratory systems may be limited or where clinicians need laboratory information during a patient visit.
PixCell and Inter Medico Build Canadian Distribution
Under the partnership, Inter Medico will support the Canadian commercialization of HemoScreen. The company has established experience in supplying diagnostic products and laboratory technologies to healthcare organizations across Canada. By combining this distribution network with PixCell Medical’s hematology platform, the partnership is intended to accelerate access to decentralized CBC testing for Canadian healthcare providers. The collaboration is also expected to support customer education, implementation and ongoing availability of the diagnostic system as adoption expands. The Canadian expansion follows HemoScreen’s regulatory and commercial development in other international markets. PixCell Medical has been expanding the availability of its technology across healthcare systems seeking alternatives to centralized laboratory testing for selected diagnostic applications. The company’s approach is based on bringing laboratory-quality hematology testing closer to the patient, potentially reducing delays associated with transporting specimens to centralized laboratories. For healthcare providers, rapid CBC results can provide clinically useful information when evaluating conditions involving infection, inflammation, anemia and other abnormalities in blood-cell parameters.
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Point-of-Care Hematology Supports Decentralized Care
The expansion highlights the growing role of point-of-care diagnostics and decentralized laboratory testing in modern healthcare. Traditional hematology testing often relies on centralized laboratory infrastructure, trained laboratory personnel and specimen transportation. Point-of-care analyzers such as HemoScreen are designed to shift selected diagnostic capabilities closer to physicians and patients. Faster access to results may support more efficient clinical workflows, particularly in settings where laboratory turnaround time can influence treatment decisions. For cGxP.wire readers, PixCell Medical’s Canadian expansion is significant from both medical-device regulatory and diagnostic-technology perspectives. The Health Canada Class III licence demonstrates the regulatory pathway required for commercialization of higher-risk IVD technologies, while the partnership with Inter Medico illustrates how manufacturers can use established regional distribution networks to expand market access. The launch also reflects continuing innovation in microfluidics, automated hematology and point-of-care testing. As decentralized diagnostics become increasingly important, technologies capable of delivering rapid and reliable laboratory information outside traditional laboratories may play a growing role in healthcare delivery. The Canadian availability of HemoScreen adds another market to PixCell Medical’s international expansion strategy while strengthening access to rapid CBC testing for healthcare professionals.
Source: PixCell Medical press release
