Quality Management System Certification Marks Secret Regulatory Milestone for Light AI’s software application as a Medical Device System
VANCOUVER, BC , June 29, 2026 / CNW/ – Light AI Inc. (“Light AI” or the “Business”) (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF) an expert system health and wellness innovation company developing Software as a Medical Device (“SaMD”) remedies, is pleased to announce that it has actually successfully finished its High quality Monitoring System”” audit and has been certified as remaining in conformity with ISO 13485: 2016 and the Medical Gadget Solitary Audit Program (“MDSAP”) by Intertek.
The MDSAP accreditation confirms that Light AI’s quality monitoring system satisfies internationally recognized criteria for the style, growth, manufacture, and circulation of AI/ML powered devices used to screen, display, and help in the discovery of ENT infections administration of clinical devices and Software program as a Clinical Device innovations for Canada, the USA and Australia.
Achievement of MDSAP and ISO 13485 certification represents a significant regulative turning point for the Business and supports its planned regulatory entries for its QuickScan and QuickScan Strep A software systems in Canada.
The qualification covers the Firm’s quality monitoring procedures connected with the development of QuickScan software-based clinical technologies and establishes the operational framework called for to support ongoing regulatory, scientific, and commercialization activities.
“As we proceed executing our regulatory technique, attaining MDSAP and ISO 13485 accreditation is an essential achievement for Light AI,” stated John R. Luna, Ceo of Light AI. “This accreditation demonstrates our dedication to preserving a robust clinical gadget high quality monitoring system and shows the considerable work completed by our team to align our procedures with worldwide identified medical tool standards. With this milestone attained, we are placed to advance our prepared Wellness Canada regulatory submissions for QuickScan Strep A.”
The Firm’s QuickScan Strep A system is being established as Software program as a Clinical Gadget solutions planned to sustain health care experts in the evaluation of patients offering with signs and symptoms constant with pharyngitis and possible Group A Streptococcus (“Strep A”) infection.
MDSAP enables acknowledged auditing organizations to perform a solitary regulative audit of a clinical device supplier’s high quality monitoring system that satisfies the requirements of several participating governing territories consisting of Canada, Australia and the USA. ISO 13485 is the worldwide identified quality management standard particular to the clinical gadget sector and is commonly made use of by regulatory authorities and manufacturers worldwide.
Light AI believes that conclusion of its MDSAP and ISO 13485 qualification develops a crucial foundation for future regulatory submissions, consisting of the Business’s intended Health Canada Medical Device License application for QuickScan Strep A.
The Firm will certainly continue to progress its regulatory, medical validation, and commercialization tasks and expects to offer updates pertaining to Health and wellness Canada entry timing and other crucial milestones as appropriate.
About Light AI Inc. (CBOE CA: ALGO/ FSE: OHC/ OTCQB: OHCFF)
Light AI Inc. is a modern technology business concentrated on developing expert system health testing and analysis options. Light AI QuickScan is a modern technology platform which represents the next generation of person monitoring: it uses AI formulas to suitable clever gadget images, beginning with photos of Strep A and anticipated development with various other medical conditions, to determine the condition in seconds. Its trademarked, app-based service calls for no swabs, lab tests or exclusive hardware of any kind as its computer platform consists of the 4 5 billion smart devices that exist worldwide today. Light AI is at the center of developing ingenious screening and diagnostic options targeted at improving healthcare distribution worldwide. Their advanced AI powered modern technology supplies fast, precise, and economical testing and diagnostic devices made to resolve essential health care challenges.
In pre-FDA recognition research studies, Light AI’s formula showed remarkable accuracy in setting apart in between viral and microbial pharyngitis, particularly targeting Team A Streptococcus (GAS). The formula accomplished a 96 57 % precision price and achieved a Negative Anticipating Worth of 100 %, indicating its high dependability in verifying the lack of Streptococcus A infection. Viral and GAS pharyngitis impacts over 600 million people every year worldwide. If left unattended, GAS pharyngitis can result in serious problems such as Rheumatic Heart Disease (RHD), which imposes a worldwide economic worry exceeding $ 1 trillion annually. Light AI’s technology offers a considerable advancement in the exact and prompt recognition of GAS pharyngitis, possibly reducing the occurrence of RHD and its associated expenses. Light AI’s approach to using AI to wise gadget photos can be increased to other clinical problems, along with other areas of evaluation. Light AI’s vision is to incorporate the Light AI QuickScan software platform with AI in-the-Cloud to produce a Digital Professional Lab that provides fast and obtainable diagnosis for numerous problems that today require pricey and time-consuming imaging or lab processes.
ON PART OF THE BUSINESS
“John R. Luna”
Ceo
Telephone: 1 -( 888 804 – 9459
Email: [email protected]
Website: https://light.ai/
LinkedIn: LinkedIn/company/Light AI
X (Previously Twitter): @lightaihealth
Forward-Looking Information:
This news release consists of statements and details that, to the level that they are not historical fact, make up “forward-looking info” within the meaning of relevant safety and securities legislation, including statements associating with its expected regulatory submissions for the Company’s QuickScan and QuickScan Strep A software application platforms in Canada; the Firm’s business strategy; and QuickScan Strep A system being established as Software application as a Medical Gadget options and that it will certainly sustain health care professionals in the assessment of patients. Positive information is based on the reasonable presumptions, estimates, evaluation and opinions of management made because of its experience and its perception of trends, existing problems and anticipated growths, as well as various other aspects that administration thinks to be appropriate and practical in the circumstances at the day that such statements are made, but which might confirm to be wrong. Forward-looking info includes recognized and unknown dangers, unpredictabilities and other variables that may create the actual outcomes, efficiency or accomplishments of the Business to vary materially from any type of future outcomes, performance or accomplishments expressed or suggested by the positive information, consisting of, but not restricted to, declarations connecting to the Business’s economic performance, service advancement, results of procedures, and those detailed in filings made by the Firm with the Canadian safeties regulative authorities (which might be viewed at www.sedarplus.ca As necessary, viewers must not put undue reliance on any such progressive details. Further, any kind of positive statement speaks only as of the day on which such declaration is made. New aspects arise from time to time, and it is not feasible for the Firm’s administration to anticipate every one of such aspects and to analyze in advance the effect of each such aspect on the Company’s business or the extent to which any type of aspect, or combination of aspects, may create real results to differ materially from those contained in any type of forward-looking declarations. The Firm does not carry out any kind of commitment to update any kind of positive information to mirror information, events, results, conditions or otherwise after the date hereof or to reflect the event of unanticipated events, except as needed by law including safeties legislations.
SOURCE Light AI Inc.
For more information, please speak to the Business at [email protected] or go to https://light.ai/.