- Light AI received a Class II Medical Device License from Health Canada for QuickScan Strep A, its first product on the QuickScan AI platform. The license, No. 115921, was issued August 10, 2026.
- QuickScan Strep A is an AI-powered clinical decision support SaMD that uses machine learning and digital throat images to assist healthcare professionals assessing patients with symptoms of Group A Streptococcal pharyngitis.
- The device-agnostic QuickScan platform is designed to analyze point-of-care images using compatible digital imaging and computing technologies. The company plans to leverage its AI, image analysis and software infrastructure for additional clinical applications.
- The license enables Light AI to advance Canadian commercialization across pharmacies, clinics and other care settings. The milestone follows ISO 13485:2016 and MDSAP certification, supporting the company’s regulated device development and commercialization.
Takeaways:
Light AI’s Health Canada Class II license for QuickScan Strep A clears the way to commercialize an AI‑based clinical decision support tool that analyzes digital throat images to help clinicians assess suspected Group A strep pharyngitis in pharmacies, clinics and other point‑of‑care settings. By offering a rapid, device‑agnostic software adjunct to existing testing (e.g., RADT or culture), it could streamline triage and antibiotic decisions in Canada while giving Light AI a regulated foothold to expand the QuickScan platform to additional conditions.
Source: CA Newswire
