AiZtech Labs: The Toronto Company That Earned a World-First Approval From Saudi Arabia

Founded in Toronto in 2018, AiZtech Labs turns a smartphone camera into a vitals screening tool, and holds what it describes as the world's first full regulatory approval for camera-based measurement of blood pressure, blood oxygen and heart rate. How it got there is the notable part. The company earned its regulatory approval and its operational track record in the Gulf, then entered the American market with both behind it. This is the reverse of the usual Canadian path, which runs south first. The company chose this route because it believes in Saudi Arabia's Vision 2030, and wants to help build the future of healthcare alongside it.

What the Company Does

AiZtech Labs is a Canadian AI diagnostics company based at Toronto’s MaRS Discovery District, with  a presence at IBM Innovation Space in Markham and in Dubai. It’s led by co-founder and chief executive Mohamed Sheta.

Its platform, iSelfie BioSignals, uses remote photoplethysmography, a technique that reads subtle changes in facial blood flow from ordinary video, to produce vital sign measurements from a selfie without any dedicated hardware.

The company describes the resulting capability as clinical-grade vitals through any camera,  positioning it for both enterprise healthcare screening and general wellness use.

Its advisory board includes Ann Cavoukian, who served three terms as Ontario's Information and Privacy Commissioner, and Allan Slomovic, professor of ophthalmology at the University of Toronto and past president of the Canadian Ophthalmological Society.

The Regulatory Achievement

The most significant fact about the company is one no marketing claim could substitute for iSelfie BioSignals holds full regulatory approval from the Saudi Food and Drug Authority for AI-powered measurement of blood pressure on a calibrated basis, blood oxygen saturation and heart rate using only a smartphone camera. The company describes this as the first regulatory approval worldwide for camera-based measurement of all three, covering both home and outpatient clinical settings, and authorised for use by laypersons as well as healthcare professionals.

That matters more than any accuracy figure, because a regulator has examined the evidence and made a determination. Securing a first-of-its-kind medical software approval from a national regulator is a substantial achievement for any company.

The company also holds ISO 13485 certification, the quality management standard for medical devices, alongside AICPA and HIPAA compliance marks.

Deployment at a Difficult Scale

The approval was earned alongside real deployment. In 2024, the Makkah Health Cluster signed a cooperation agreement to deploy iSelfie across its facilities, including more than 10 hospitals in the city, including King Abdullah Medical City.

Canada's ambassador to Saudi Arabia attended the signing and noted that digital health innovation is gaining momentum in Canada and that Saudi Arabia is a market open to early adoption in the health sector.

Mohamed Sheta, Cofounder and CEO: "We built AiZtech in Toronto with a simple ambition: make health screening more accessible through the technology people already carry. Our partnership with Saudi Arabia to bring this to life shows what Canadian companies can achieve when strong science is paired with a clear human need." 

The company reports that international deployment reduced traditional intake workflows from seven minutes to two, with substantial estimated annual savings for one hospital cluster. Its platform was also used during Hajj in 2025.

Its validation base spans six clinical studies across the United States, Canada, Saudi Arabia, and Brazil, involving more than 5,000 participants.

Two Products, Two Regulatory Positions

The company now operates on both sides of a line worth understanding, and it draws that line carefully.

Its enterprise product is positioned for clinical screening contexts as described in its regulatory clearances. Its consumer wellness application is explicitly stated not to be a medical device, not intended to diagnose, treat, cure, monitor or prevent any disease. Its a general wellness software tool supporting healthy habits and self-awareness, with users encouraged to seek medical evaluation from professionals.

That separation is the correct approach and an instructive one for any Canadian business operating near a regulated boundary. The same underlying technology can be a regulated medical product in one configuration and a wellness tool in another, and the difference lies in what is claimed and in which market. Companies that blur it eventually hear from a regulator.

Why This Is a Canadian Story

AiZtech Labs is a Toronto-founded company taking Canadian innovation into international healthcare markets, with Saudi Arabia at the heart of its plans.

The United States is the latest of those markets. The company launched iSelfie BioSignals in the United States in April 2026, reporting early interest from more than 40 health systems following the HIMSS conference.

From its base in Canada, AiZtech Labs continues to expand across the Gulf and North America.

Website: iselfie.ai/enterprise

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