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PixCell Medical is expanding into Canada following the receipt of a Health Canada Class III Medical Device Licence for HemoScreen™ and through a new distribution partnership with Inter Medico, a leading Canadian provider of diagnostic instrumentation and solutions. The milestone opens the Canadian market to HemoScreen and brings rapid, laboratory-quality 5-part differential Complete Blood Count (CBC) testing closer to patients nationwide.
The Health Canada licence builds on PixCell Medical’s recent Medical Device Single Audit Program (MDSAP) certification, an important regulatory step for manufacturers bringing Class II, III and IV medical devices to the Canadian market. Together, these milestones demonstrate HemoScreen’s compliance with Canada’s regulatory requirements for quality, safety and effectiveness and represent another significant step in PixCell Medical’s continued international expansion.
At the center of HemoScreen’s Canadian expansion is Inter Medico, which will serve as PixCell Medical’s local distribution partner. With more than 45 years of experience bringing advanced diagnostic technologies to Canadian laboratories and healthcare providers, Inter Medico provides the local market knowledge and nationwide presence needed to connect HemoScreen with the healthcare settings where decentralized CBC testing can make a difference.
“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,” said Dan Lichtman, CEO of Inter Medico. “We 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.”
The Health Canada licence marks the beginning of HemoScreen’s commercial journey in Canada. Together with Inter Medico, PixCell Medical will now work to make rapid, near-patient CBC testing accessible to healthcare providers across the country.
Read the full press release announcing the Health Canada licence and partnership with Inter Medico here.
For further information about HemoScreen and availability in Canada, contact us here.