Quality Management System Certification Marks Key Regulatory Milestone for Light AI’s Software as a Medical Device Platform
VANCOUVER, BC, June 29, 2026 /CNW/ – Light AI Inc. (“Light AI” or the “Company”) (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF) an artificial intelligence health technology company developing Software as a Medical Device (“SaMD”) solutions, is pleased to announce that it has successfully completed its Quality Management System”” audit and has been certified as being in conformity with ISO 13485:2016 and the Medical Device Single Audit Program (“MDSAP”) by Intertek.
The MDSAP certification confirms that Light AI’s quality management system meets internationally recognized standards for the design, development, manufacture, and distribution of AI/ML powered devices used to screen, monitor, and assist in the detection of ENT infections management of medical devices and Software as a Medical Device technologies for Canada, the United States and Australia.
Achievement of MDSAP and ISO 13485 certification represents a significant regulatory milestone for the Company and supports its planned regulatory submissions for its QuickScan™ and QuickScan™ Strep A software platforms in Canada.
The certification covers the Company’s quality management processes associated with the development of QuickScan™ software-based medical technologies and establishes the operational framework required to support ongoing regulatory, clinical, and commercialization activities.
“As we continue executing our regulatory strategy, achieving MDSAP and ISO 13485 certification is an important accomplishment for Light AI,” said John R. Luna, Chief Executive Officer of Light AI. “This certification demonstrates our commitment to maintaining a robust medical device quality management system and reflects the significant work completed by our team to align our operations with internationally recognized medical device standards. With this milestone achieved, we are positioned to advance our planned Health Canada regulatory submissions for QuickScan™ Strep A.”
The Company’s QuickScan™ Strep A platform is being developed as Software as a Medical Device solutions intended to support healthcare professionals in the assessment of patients presenting with symptoms consistent with pharyngitis and potential Group A Streptococcus (“Strep A”) infection.
MDSAP allows recognized auditing organizations to conduct a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple participating regulatory jurisdictions including Canada, Australia and the United States. ISO 13485 is the internationally recognized quality management standard specific to the medical device industry and is widely utilized by regulators and manufacturers globally.
Light AI believes that completion of its MDSAP and ISO 13485 certification establishes an important foundation for future regulatory submissions, including the Company’s planned Health Canada Medical Device License application for QuickScan™ Strep A.
The Company will continue to advance its regulatory, clinical validation, and commercialization activities and expects to provide updates regarding Health Canada submission timing and other key milestones as appropriate.
About Light AI Inc. (CBOE CA: ALGO / FSE: OHC / OTCQB: OHCFF)
Light AI Inc. is a technology company focused on developing artificial intelligence health screening and diagnostic solutions. Light AI QuickScan™ is a technology platform which represents the next generation of patient management: it applies AI algorithms to compatible smart device images, starting with images of Strep A and anticipated expansion with other medical conditions, to identify the disease in seconds. Its patented, app-based solution requires no swabs, lab tests or proprietary hardware of any kind as its computing platform includes the 4.5 billion smartphones that exist in the world today. Light AI is at the forefront of developing innovative screening and diagnostic solutions aimed at improving healthcare delivery worldwide. Their cutting-edge AI powered technology offers rapid, accurate, and cost-effective screening and diagnostic tools designed to address critical healthcare challenges.
In pre-FDA validation studies, Light AI’s algorithm demonstrated remarkable accuracy in differentiating between viral and bacterial pharyngitis, specifically targeting Group A Streptococcus (GAS). The algorithm achieved a 96.57% accuracy rate and attained a Negative Predictive Value of 100%, indicating its high reliability in confirming the absence of Streptococcus A infection. Viral and GAS pharyngitis affects over 600 million people annually worldwide. If left untreated, GAS pharyngitis can lead to serious complications such as Rheumatic Heart Disease (RHD), which imposes a global economic burden exceeding $1 trillion annually. Light AI’s technology offers a significant advancement in the accurate and timely identification of GAS pharyngitis, potentially reducing the incidence of RHD and its associated costs. Light AI’s approach to applying AI to smart device images can be expanded to other medical conditions, as well as other areas of analysis. Light AI’s vision is to combine the Light AI QuickScan™ software platform with AI in-the-Cloud to create a Digital Clinical Lab that provides quick and accessible diagnosis for countless conditions that today require expensive and time-consuming imaging or lab processes.
ON BEHALF OF THE COMPANY
“John R. Luna”
Chief Executive Officer
Telephone: 1-(888) 804-9459
Email: jluna@light.ai
Website: https://light.ai/
LinkedIn: LinkedIn/company/Light AI
X (Formerly Twitter): @lightaihealth
Forward-Looking Information:
This news release contains statements and information that, to the extent that they are not historical fact, constitute “forward-looking information” within the meaning of applicable securities legislation, including statements relating to its anticipated regulatory submissions for the Company’s QuickScan™ and QuickScan™ Strep A software platforms in Canada; the Company’s business plan; and QuickScan™ Strep A platform being developed as Software as a Medical Device solutions and that it will support healthcare professionals in the assessment of patients. Forward-looking information is based on the reasonable assumptions, estimates, analysis and opinions of management made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, including, but not limited to, statements relating to the Company’s financial performance, business development, results of operations, and those listed in filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedarplus.ca). Accordingly, readers should not place undue reliance on any such forward-looking information. Further, any forward-looking statement speaks only as of the date on which such statement is made. New factors emerge from time to time, and it is not possible for the Company’s management to predict all of such factors and to assess in advance the impact of each such factor on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. The Company does not undertake any obligation to update any forward-looking information to reflect information, events, results, circumstances or otherwise after the date hereof or to reflect the occurrence of unanticipated events, except as required by law including securities laws.
SOURCE Light AI Inc.
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