Announcement • Aug 14

Light Ai Inc Receives Health Canada Medical Device License for Quickscan Strep A

Light AI Inc. had Health Canada issue Medical Device License No. 115921 for LIGHT AI QUICKSCAN STREP A, classified as a Class II medical device, with a first issue date of August 10, 2026. The Health Canada listing identifies the device as LAI-QS-A-001. The license represents a major regulatory milestone for Light AI and enables the Company to advance toward the commercial introduction of QuickScan Strep A in Canada. QuickScan Strep A is an AI-powered clinical decision support SaMD designed to assist healthcare professionals in the assessment of patients presenting with symptoms consistent with Group A Streptococcal pharyngitis. The software uses machine learning and digital images of the throat to provide healthcare professionals with rapid clinical decision support at the point of care. QuickScan is being developed as a device-agnostic SaMD platform, designed to use compatible digital imaging and computing technologies to acquire and analyze images at the point of care. This approach is intended to provide Light AI with flexibility to integrate its software across compatible hardware platforms and healthcare environments as the Company expands its product portfolio. QuickScan Strep A represents the first commercial application of this platform, with Light AI's longer-term strategy focused on leveraging its artificial intelligence, image analysis and software infrastructure across additional clinical applications. The Health Canada license follows another significant regulatory milestone for the Company: the achievement of ISO 13485:2016 and Medical Device Single Audit Program certification, establishing the quality management system foundation supporting Light AI's regulated medical device development and commercialization activities. Light AI expects to provide additional information regarding its Canadian commercialization plans, partnerships and anticipated product availability as those initiatives progress. The Company's core technology, Light AI QuickScan, is a device-agnostic software platform that applies proprietary artificial intelligence and machine learning algorithms to medical images to provide healthcare professionals with actionable clinical information within seconds. The QuickScan platform is designed to operate across compatible imaging and computing hardware, providing flexibility for integration into a range of healthcare devices, clinical workflows and care settings without dependence on a single proprietary hardware platform. The first product being brought to market on the platform, Light AI QuickScan Strep A, uses artificial intelligence to analyze images of the throat and provide clinical decision support regarding the likelihood of Group A Streptococcal pharyngitis. QuickScan Strep A is designed to provide a rapid, non-invasive assessment without requiring a throat swab or laboratory test as part of the QuickScan analysis. Light AI is developing the QuickScan platform with the potential to support additional medical conditions and clinical applications over time. The Company's long-term vision is to combine its QuickScan SaMD platform, advanced imaging, and cloud-based artificial intelligence to create a scalable Digital Clinical Lab capable of delivering rapid and accessible clinical insights across multiple diseases and conditions. In pre-FDA validation studies, Light AI's Strep A algorithm demonstrated 96.57% accuracy in differentiating between viral and bacterial pharyngitis and achieved a Negative Predictive Value of 100% for Group A Streptococcus. Viral and Group A Streptococcal pharyngitis affect hundreds of millions of people globally each year, and untreated Group A Streptococcal infection can result in serious complications, including rheumatic heart disease. Light AI believes its device-agnostic software architecture and artificial intelligence platform have the potential to expand access to rapid clinical decision support across diverse healthcare environments worldwide.

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