DIAGNOS receives Saudi FDA license for CARA retinal imaging system

DIAGNOS Receives Saudi FDA Medical Device License for CARA System, Bringing AI-Assisted Retinal Image Analysis to Saudi Arabia

BROSSARD, Quebec, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Corporation dedicated to the early detection of eye-related health using Artificial Intelligence (AI) techniques, is pleased to announce that today, August 13, 2026, it has received Medical Device Marketing Authorization for the CARA System (CARA) from the Saudi Food and Drug Authority (SFDA).

The version of CARA licensed in Saudi Arabia includes detection algorithms for Diabetic Retinopathy (DR) and Age-related Macular Degeneration (AMD). CARA provides, in a short period of time and at an affordable unit cost, valuable insights to the healthcare provider, ultimately improving quality of life for the patient.

According to the International Diabetes Federation (link), the adult population in Saudi Arabia was 25 million people in 2024 with a prevalence of diabetes of 23%, representing an addressable market of over 5 million adults to be screened regularly for DR and AMD.

“Registering and receiving the authorization to market the CARA platform in Saudi Arabia from the SFDA represents a milestone in our commercialization efforts for Saudi Arabia” said Yves-Stephane Couture, COO of DIAGNOS.

"For more than a decade, DIAGNOS has been developing retinal image analysis using AI technologies through collaborations with clinicians and healthcare organizations worldwide, driven by one mission - help prevent avoidable blindness," said André Larente, President and Chief Executive Officer of DIAGNOS." “Following our recent approval from Health Canada announced on July 27, 2026, this additional approval opens new sales opportunities beyond North America”.

"The SFDA authorization of CARA is an important achievement not only for DIAGNOS, but also for Quebec's innovation ecosystem," said Philippe Couillard, Chairman of the Board of DIAGNOS.

DIAGNOS main strategy to address the Saudi Arabia market is to rely on local agents and distributors. As such, DIAGNOS works with a local distributor, Kanhoor Medical, a company providing telemedicine and remote patient treatment.

About DIAGNOS
DIAGNOS is a public Canadian corporation dedicated to the early detection of critical eye-related health problems. By developing innovative products based on AI technologies, DIAGNOS’ solutions provide healthcare clinicians with valuable information that refines diagnostic accuracy, streamlines workflows, and improves patient outcome.

Additional information is available at www.diagnos.com and www.sedarplus.com.

This news release contains forward-looking information. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in these statements. DIAGNOS disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise. The forward-looking information contained in this news release is expressly qualified by this cautionary statement.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact:
Mr. André Larente, President
DIAGNOS Inc.
Tel: 450-678-8882 ext. 224
alarente@diagnos.ca