Light AI Receives Health Canada Medical Device License for QuickScan™ Strep A
Light AI Receives Health Canada Medical Device License for QuickScan™ Strep A |
| [12-August-2026] |
Health Canada Class II medical device license represents a major regulatory milestone and enables commercialization of Light AI's first AI-powered Software as a Medical Device in Canada VANCOUVER, BC, Aug. 12, 2026 /CNW/ -- Light AI Inc. ("Light AI" or the "Company") (Cboe Canada: ALGO) (Frankfurt: 0HC) (OTCQB: OHCFF), an artificial intelligence healthcare technology company focused on developing Software as a Medical Device ("SaMD") solutions, is pleased to announce that Health Canada has issued a Class II Medical Device License for Light AI QuickScan™ Strep A, the Company's first product developed on its QuickScan™ artificial intelligence platform. Health Canada issued 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 ("GAS") 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. "Receiving our Health Canada Medical Device License for QuickScan™ Strep A is a defining milestone for Light AI," said John R. Luna, Chief Executive Officer of Light AI. "We have spent years developing the technology, building the clinical evidence, establishing a world-class quality system and preparing the Company to transition from product development to commercialization. Today, that transition becomes a reality." Mr. Luna continued: "Canada represents an ideal first commercial market for QuickScan™ Strep A. Our vision is to provide healthcare professionals with rapid, accessible and scalable AI-powered clinical decision support that can help improve the assessment of sore throat patients while fitting efficiently into existing healthcare workflows. With Health Canada licensing now achieved, our focus shifts to commercial execution and bringing QuickScan™ Strep A to healthcare providers and patients across Canada." Advancing QuickScan™ Device-Agnostic AI Software Platform 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 (MDSAP) certification, establishing the quality management system foundation supporting Light AI's regulated medical device development and commercialization activities. Commercialization in Canada With the Health Canada license now issued, Light AI intends to advance its Canadian commercialization strategy, including engagement with healthcare providers and potential distribution and commercial partners. The Company believes Canada provides an attractive opportunity for QuickScan™ Strep A across multiple points of care, including community pharmacies, medical clinics and other healthcare settings where patients commonly present with sore throat symptoms. Light AI expects to provide additional information regarding its Canadian commercialization plans, partnerships and anticipated product availability as those initiatives progress. "This is not the finish line; it is the starting point for the commercial phase of Light AI," Mr. Luna added. "Our team has accomplished an extraordinary regulatory milestone, and we are now focused on translating that achievement into adoption, revenue and, most importantly, meaningful benefits for healthcare professionals and their patients." About Light AI Inc. Light AI Inc. is a healthcare technology company focused on developing artificial intelligence-powered Software as a Medical Device (SaMD) solutions designed to support rapid, accessible clinical assessment at the point of care. 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 GAS 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 combineh 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 GAS pharyngitis affect hundreds of millions of people globally each year, and untreated GAS 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. ON BEHALF OF THE COMPANY "John R. Luna" Website: https://light.ai/ Forward-Looking Information: This news release includes information, statements, beliefs and opinions which are forward-looking, and which reflect current estimates, expectations and projections about future events, including, but not limited to, the Company's Canadian commercialization strategy and plans for QuickScan™ Strep A, anticipated engagement with healthcare providers and potential distribution and commercial partners, anticipated product availability, the Company's device-agnostic SaMD platform and potential expansion into additional clinical applications, the Company's regulatory strategy, the Company's business strategy, development plans and market opportunities, and other statements that contain words such as "believe," "expect," "project," "should," "seek," "anticipate," "will," "intend," "positioned," "risk," "plan," "may," "estimate" or, in each case, their negative and words of similar meaning. By its nature, forward-looking information involves a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking information. These risks, uncertainties and assumptions could adversely affect the outcome of the plans and events described herein. Readers should not place undue reliance on forward-looking information, which is based on the information available as of the date of this news release. For a list of the factors that may affect any of the Company's forward-looking statements, please refer to the Company's annual information form dated April 14, 2025 and other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed under its SEDAR+ profile at www.sedarplus.ca). Light AI disclaims any intention or obligation to update or revise any forward-looking information contained in this news release, whether as a result of new information, future events or otherwise, unless required by applicable law. The forward-looking information included in this news release is expressly qualified in its entirety by this cautionary statement. SOURCE Light AI Inc. | ||
Company Codes: Frankfurt:0HC,NEO:ALGO,OTC-BB:OHCFF,OTC-QB:OHCFF |
