A Mexico City startup has achieved the Western Hemisphere’s first SaMD regulatory approval for its proprietary AI-powered diagnostic software, offering a potential roadmap for healthcare systems in other regions facing budget cuts and chronic disease epidemics
In a cramped apartment in the outskirts of Puebla far away from a fully equipped state hospital, Maria Elena Hernandez takes what looks like an ordinary selfie with her smartphone. But in the 70 seconds it takes to record her video, artificial intelligence algorithms are measuring more than 20 vital signs and biomarkers — including blood pressure, heart rate, and blood oxygen levels — with medical-grade accuracy.
Hernandez, 54, doesn’t know it yet, but the AI has detected subtle signs of hypertension that traditional screenings might miss for years. In Mexico, where 65% of hypertension cases go undiagnosed until they trigger medical emergencies, this early detection could literally save her life.
More remarkably, Medsi’s AI goes beyond collecting vital signs, analyzing them against a complete health profile, cross-referencing medical literature, and generating personalized health insights that rival those of a panel of medical specialists.
Within minutes, the system produces a comprehensive health report in plain language while simultaneously generating clinical-grade analysis for healthcare providers.
This isn’t science fiction. It’s the breakthrough technology behind Medsi AI, a Mexico City-based startup that just achieved a historic regulatory milestone: becoming the first company in the Western Hemisphere to secure Class II Software as a Medical Device (SaMD) approval from COFEPRIS, Mexico’s equivalent of the FDA.
The achievement comes as Mexico grapples with a healthcare crisis that traces back to an unexpected source, the original NAFTA agreement.
The 1994 trade deal that transformed Mexico’s economy also flooded the country with processed foods and sugary drinks, creating what public health experts call one of the world’s most severe chronic disease epidemics.
Other key contributors to Mexico’s urgent health crisis include its population’s predisposition to Type 2 diabetes, making them more susceptible to developing the condition, and socio-economic inequalities such as lower income levels, less access to education and healthcare, and cultural perceptions which can all exacerbate chronic disease conditions.
The NAFTA Health Legacy
“NAFTA brought economic opportunities, but it also brought sugary drinks to every corner store,” says Manuel Villalvazo, CEO and co-founder of Medsi AI. “Today, it’s often cheaper and more accessible for a child in rural Mexico to drink soft drinks than clean water. We’re still paying the health price for that transformation three decades later.”
The statistics are staggering. Mexico now ranks among the world’s highest for diabetes and hypertension rates, with 74% of deaths stemming from non-communicable diseases. Half the population lacks adequate healthcare coverage, while families shoulder some of the world’s highest out-of-pocket healthcare spending rates.
But Mexico’s crisis may preview challenges facing other North American healthcare systems. In the U.S., proposed Medicare cuts and reduced reimbursement rates threaten access for millions, while chronic diseases linked to similar dietary patterns continue climbing.
“What we’re solving in Mexico today may be exactly what mature healthcare markets need tomorrow,” Villalvazo notes. “When traditional healthcare systems can’t scale to meet demand, technology-enabled solutions become not just helpful, but essential.”
The Smartphone Medical Revolution
However, the 70-second smartphone capture represents just the beginning of Medsi’s innovation. The real breakthrough happens after the data collection ends. The platform’s true power lies in its artificial intelligence architecture that doesn’t just gather health metrics but interprets them with the sophistication of medical specialists.
“When light from a smartphone’s camera hits your skin, some is absorbed by blood vessels underneath,” explains Jorge Hinojosa, Medsi’s COO and co-founder. “These subtle variations in light absorption, invisible to the naked eye, contain rich physiological information that our AI algorithms can decode.”
Medsi AI’s platform measures vital signs including heart rate, blood pressure, respiratory rate, oxygen saturation, and stress indicators, all without requiring contact with the skin or specialized hardware.
Its proprietary Retrieval-Augmented Generation layer, with patents pending from the Mexican Intellectual Property Institute (IMPI) and the United States Patent & Trademark Office (USPTO), represents a fundamental shift from simple pattern-matching to genuine clinical reasoning. The AI doesn’t just correlate symptoms with conditions based on statistical patterns. It analyzes complex interrelationships between different health parameters, considers contextual factors like medical history and lifestyle, and generates insights that mimic the nuanced thinking of an entire medical team.
“Think of it as having access to a team of specialists who never sleep,” Hinojosa adds. “Our AI can simultaneously assess cardiovascular risk while evaluating diabetic indicators, checking for medication interactions, and recommending preventive care — all while adapting its communication style based on whether it’s talking to a patient or a healthcare provider.”
Clinical Validation and Real-World Impact
The technology’s effectiveness has been demonstrated through clinical trials and corporate pilot programs across Mexico. In corporate wellness implementations, Medsi has achieved sustained user engagement rates above 60% after 30 days, triple the typical retention rate for healthcare apps.
More importantly, the engagement translates to measurable health improvements. Users who consistently engage with the platform show statistically significant improvements in key health markers, including blood pressure and blood glucose control.
“We’re seeing early detection of chronic conditions months or even years before they’d typically be diagnosed in traditional clinical settings,” Villalvazo says. “That early intervention window is when treatment is most effective and affordable.”
The AI’s clinical reasoning capabilities prove particularly valuable in Mexico’s resource-constrained environment. “Our system can identify which patients need immediate specialist referrals versus continued monitoring, helping providers prioritize their limited time,” Hinojosa notes. “It’s like having a resident physician who’s analyzed thousands of similar cases instantly available for every consultation.”
For corporate clients, the results include reduced healthcare-related absenteeism and improved employee productivity. In Mexico’s workforce, where untreated chronic conditions often force employees to leave jobs to care for family members, these improvements carry significant economic implications.
The platform’s behavioral science approach, incorporating personalized gamification elements, adapts to individual user motivation patterns. Rather than one-size-fits-all health advice, Medsi learns whether users respond better to achievement-oriented challenges, community-based support, or anxiety-reducing guidance.
Strategic Investment and Market Validation
The technology’s potential has attracted backing from Laboratorios Sanfer, Mexico’s largest private pharmaceutical company, which led Medsi’s $3 million Seed 1 funding round. Sanfer is partly owned by global investment giants CDPQ and General Atlantic, adding significant credibility to the investment.
“Our strategic investment in Medsi AI aligns perfectly with Sanfer’s mission to contribute to health and well-being,” says Ricardo Amtmann Aguilar, CEO and Chairman of Laboratorios Sanfer. “By supporting technology that makes preventive healthcare accessible through devices already in people’s pockets, we’re helping address Mexico’s most pressing health challenges while creating a more sustainable healthcare model.”
The investment timing coincides with surging North American interest in AI-powered healthcare solutions. According to Silicon Valley Bank, $5.6 billion was invested in AI-backed healthcare companies in 2024, nearly triple the previous year. CB Insights reports that digital health funding reached $5.3 billion in Q1 2025, up 47% quarter-over-quarter.
Regulatory Breakthrough Opens New Possibilities
Medsi’s Class II SaMD approval from COFEPRIS represents more than a regulatory checkbox. It validates that smartphone-based software can meet the same rigorous standards as hospital-grade medical devices for diagnosis and monitoring.
“This designation means our platform can perform actual medical diagnosis and monitoring functions independently,” Villalvazo explains. “What’s particularly significant is that we achieved this approval based on our AI’s clinical reasoning capabilities, not just vital sign collection, so it meets the same standards as traditional medical devices.”
The regulatory pathway required extensive clinical validation, quality management systems, and post-market surveillance capabilities. The achievement creates significant competitive advantages and barriers to entry in what Medsi estimates is a rapidly growing $46 billion total addressable market for primary care and screening.
The platform’s scalability through existing smartphone infrastructure makes it particularly attractive for healthcare systems facing budget constraints, offering population-level health insights that can inform resource allocation and policy decisions by leveraging devices already in users’ pockets.
“We’re not trying to replace traditional healthcare — we’re enhancing it with technology that makes it more efficient and effective,” Hinojosa emphasizes. “In countries facing physician shortages and uneven specialist distribution, this augmentation approach allows us to extend the reach and amplify the impact of existing healthcare workforces.”
The Health 3.0 Revolution
Medsi AI’s approach represents what industry experts call the Health 3.0, where AI doesn’t replace human medical expertise but amplifies it.
“Our system provides the kind of comprehensive analysis that would typically require a team of specialists working together,” Villalvazo explains. “But it delivers those insights instantly, in multiple languages, and adapts its recommendations based on each individual’s unique health profile and cultural context.”
The approach proves particularly relevant as healthcare systems worldwide face similar pressures: aging populations, rising chronic disease prevalence, and constrained budgets. Mexico’s experience with NAFTA-driven dietary changes and resulting health challenges may serve as both warning and solution for other markets undergoing similar transitions.
“We’re solving a crucial societal challenge by democratizing access to sophisticated preventive care through devices people already carry,” Villalvazo concludes. “This isn’t just a good business opportunity — it’s a vital investment in Mexico’s future, and potentially the future of healthcare worldwide.”
Chris Knight is a Grit Daily Leadership Network contributor and a seasoned communications expert with 30 years of experience in mass media, PR, and marketing. He is the co-founder of MOUSA.I., a new A.I. marketing agency in San Francisco, as well as the co-founder of Divino Group.