MeMed Expands Global Footprint as Health Canada Approves MeMed BV® on MeMed Key®
ANDOVER, Mass. and HAIFA, Israel, March 25, 2026 /CNW/ -- MeMed, a leader in host-response technology, today announced that Health Canada has granted Medical Device License (MDL) for MeMed BV® on the MeMed Key® platform.
This approval introduces a breakthrough in immune-based diagnostics to the Canadian healthcare market, providing clinicians with a highly accurate tool to distinguish between bacterial and viral infections in just 15 minutes.
In Canada, sepsis remains a significant driver of mortality and hospital utilization -contributing to approximately one in 18 deaths¹, while antimicrobial resistance (AMR) continues to rise as a major public health threat.² In acute care, diagnostic uncertainty often leads to inappropriate antibiotic use, either underuse resulting in delayed treatment or overuse contributing to antimicrobial resistance (AMR). MeMed BV accurately distinguishes between bacterial and viral infections in children and adults based on the body's immune response. This tool supports clinicians in making timely, appropriate treatment decisions, including in suspected sepsis and respiratory tract infections, where early and accurate differentiation can be life-saving, as well as appropriate and timely dispositioning of the patient.
Proven Clinical Evidence
The MeMed BV® test is already a leading solution in host-response diagnostics worldwide:
- 100,000+ patients supported to date.
- 200+ healthcare sites utilizing the technology worldwide.
- Validated by extensive real-world evidence showing potential reductions in Emergency Department wait times³ and length of stay⁴, hospitalization duration⁵, and overall healthcare costs.⁶
With this approval, the technology becomes accessible across diverse medical environments and care settings; MeMed Key® delivers rapid results from a small blood sample in a compact system, while MeMed BV is also available on the Diasorin LIAISON® platform for high-throughput laboratories, enabling both decentralized and centralized testing.
"This approval marks a significant milestone in bringing innovative diagnostics to Canadian clinicians and patients," said Troy Boutelle, President of MeMed USA. "In settings where early identification of bacterial infections, particularly those that may progress to sepsis, is critical, MeMed BV delivers actionable insights within minutes. Together with our partners at Diasorin, we are enabling broader adoption of MeMed BV and supporting healthcare systems in delivering faster, more informed care while advancing antimicrobial stewardship."
Jeff Kormos, VP and GM at Diasorin Canada, added: "By integrating MeMed BV technology with our LIAISON® platform, alongside the rapid capabilities of MeMed Key®, we are enabling a hub-and-spoke model that connects centralized laboratories with decentralized testing environments. As adoption grows in central labs, expanding access in decentralized and frontline care settings will be critical to unlocking the full clinical and operational value of this approach across Canada."
The Canadian license represents a further step in MeMed's global expansion and its mission to translate host-response signals into actionable insights.
About MeMed
At MeMed, our mission is to translate the immune system's complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society.
MeMed BV® is the first FDA-cleared host-immune response test for accurately distinguishing between bacterial and viral infections in 15 minutes, based on the body's immune response.
MeMed BV Flex™ has received FDA Breakthrough Device Designation as a host-response test designed to distinguish between bacterial and viral infections using a few drops of capillary blood and is intended for use across hospitals as well as CLIA-waived and decentralized care settings. *MeMed BV Flex™ is an investigational device and has not been approved or cleared for sale by any regulatory authority.
MeMed Severity™ has received FDA Breakthrough Device Designation as a host-response test designed to predict severe outcomes up to 72 hours and mortality 14 days in advance in patients with acute infections and suspected sepsis. *MeMed Severity is not yet cleared for sale in any territory.
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References:
- Statistics Canada. Deaths involving sepsis in Canada.
https://www150.statcan.gc.ca/n1/pub/82-624-x/2016001/article/14308-eng.htm - Public Health Agency of Canada. Healthcare-associated infections and antimicrobial resistance in Canadian hospitals, 2018–2022.
https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-dis - LoVerde A et al. JACEP Open. https://www.jacepopen.com/article/S2688-1152(25)00213-9/fulltext
- Shapiro NI et al. JACEP Open. https://www.jacepopen.com/article/S2688-1152(25)00203-6/fulltext
- Van Houten CB et al. Pediatrics. https://doi.org/10.1542/peds.2024-069961
- Stein M et al. BMC Pediatrics. https://link.springer.com/article/10.1186/s13052-025-02185-3
SOURCE MeMed
MeMed Contact: Sahar Dorkam, Marketing Communications Manager, [email protected]
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