As 2025 comes to a close, Foqus Technologies is proud to reflect on a year defined by achievement and growth. Across different functions, we have reached pivotal milestones that strengthen our foundation and position us for a transformative 2026. We are pleased to share these highlights and celebrate the progress that brings us closer to delivering next-generation MRI innovation to the world.
Regulatory Success: FDA 510(k) Clearance
One of Foqus’s most important achievements of 2025 was obtaining its first FDA 510(K) clearance for its AI-powered MRI acceleration software, DeepFoqus-Accelerate, enabling us to distribute the software to the U.S. market. This marks one of our most significant achievements of 2025.
510(k) Premarket Notification: K241982
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241982
Regulatory Success: Health Canada Approval
Following FDA 510(K) clearance, DeepFoqus-Accelerate also received the Health Canada Medical Device License in 2025. With these regulatory approvals, the software can be launched and used in a real-world clinical environment, allowing us to approach potential early adopters, offer tailored pilot programs, and pursue further collaboration opportunities in the U.S. and Canada.
Health Canada Medical Device Licence: 113256
Strengthened by Funding and Advisory Support
In 2025, Foqus received critical support through several government-funded programs, including the National Research Council of Canada – Industrial Research Assistance Program and OBIO®’s Life Sciences Critical Technologies & Commercialization (LSCTC) Centre of Excellence. These programs will help Foqus reduce financial barriers and enable Foqus to invest more deeply in advanced R&D, positioning us for long-term competitive advantage.
Successful Pilot Study Completion
A pilot study, conducted in partnership with the Robarts Research Institute, was completed and delivered strong evidence demonstrating our software’s performance and impact, generating new opportunities, collaboration requests, and industry interest. A case study outlining the results was then developed and released. The results, which provide strong evidence of the software’s performance, will be published, driving new collaborations and market traction.
New Website Launch for Digital Presence Enhancement
Foqus launched a redesigned website featuring an improved UI/UX, enhanced branding, and more comprehensive content about our technology and vision. The new website serves as a central platform for customer education, partner engagement, and strategic marketing to enhance our visibility and credibility in the medical imaging space.
Expanding Market Reach Through a Webinar with Mohawk Medbuy
In partnership with Mohawk Modbuy, a well-known strategic sourcing, procurement, and supply chain solution provider, Foqus hosted its first joint webinar in 2025, generating strong interest and opening new conversations with potential early adopters to advance market reach.
Next year, our top priority is to shape and execute our Go-to-Market (GTM) plans. Supported by other key initiatives, the goal is to acquire first customers in 2026 and deliver innovative MRI acceleration solutions that make a meaningful impact in healthcare.
