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Medsi AI's Platform Is Approved as the First Class II Software as a Medical Device (SaMD) for Preventive Health in the Western Hemisphere


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Medsi AI

May 28, 2025, 10:11 ET

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Medsi AI rPPG Facial Scan at 70 percent
Medsi AI rPPG Facial Scan at 70 percent

Backed by strategic investor Laboratorios Sanfer, partly owned by General Atlantic and CDPQ, Medsi AI is addressing Mexico's critical healthcare challenges by teaming up with a growing number of government and public-health agencies, healthcare providers, pharmacies and corporations

MEXICO CITY, May 28, 2025 /PRNewswire-PRWeb/ -- Medsi AI (www.medsi.ai), a Mexican Health 3.0 innovator, today announced the launch of a groundbreaking digital health platform powered by its proprietary AI algorithms that transform any smartphone into a sophisticated medical diagnostic tool. Powered by Medsi AI, the new platform makes preventive healthcare accessible to millions of Mexicans through the mobile devices already in their pockets.

By taking a 70-second "video selfie" with any computing device with a camera like those found in a smartphone, the new platform can measure more than 20 vital signs and biomarkers, including heart rate, blood pressure, oxygen saturation, respiration rate, and stress & recovery indicators.

By taking a 70-second "video selfie" with any computing device with a camera like those found in a smartphone, the new Medsi AI platform can measure more than 20 vital signs and biomarkers.

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The platform powered by Medsi AI, is the first in the Western Hemisphere to secure approval as a Class II Software as a Medical Device (SaMD) by COFEPRIS, Mexico's FDA equivalent, a milestone that establishes Medsi as a health-tech leader, transforming smartphones into sophisticated diagnostic tools with medical-grade accuracy.

"Medsi AI represents a fundamental shift in how we approach healthcare in Mexico," said Manuel Villalvazo, CEO and co-founder of Medsi AI. "For the first time, through our B2B and B2G partner channels, any Mexican with a smartphone can now receive hospital-grade health screenings anytime from anywhere within two minutes. Our platform can detect subtle signs of chronic conditions like diabetes and hypertension months or even years before they'd typically be diagnosed in traditional clinical settings, allowing for early intervention when it's most effective and affordable."

Today, the Mexico City-based upstart also announced it has secured USD $3 million in Seed 1 funding led by Sanfer Farma, Mexico's largest private market pharmaceutical company that is partly owned by leading global investment groups CDPQ and General Atlantic, to accelerate its mission of transforming how Mexicans monitor and manage their health.

"At Laboratorios Sanfer, our main goal is to contribute to the health and well-being of all people," said Ricardo Amtmann Aguilar, CEO and Chairman of Laboratorios Sanfer. "Our strategic investment in Medsi AI aligns perfectly with Sanfer's mission. By supporting technology that makes preventive healthcare accessible through devices already broadly in people's pockets across the country, we're helping address Mexico's most pressing health challenges while creating a more accessible and sustainable healthcare model for the future."

"We feel extremely fortunate to be backed by the smartest money in Mexican healthcare," noted Villalvazo. "As some of the most prominent names in the industry, our strategic investors' sponsorship is a powerful validation of what we are building, and their operational backing has been invaluable as we scale the business."

Medsi AI's platform launch timing is a timely example of North American investments in AI-based healthcare surging, with $5.6 billion invested in AI-backed healthcare companies in 2024, per Silicon Valley Bank — nearly triple the previous year. According to CB Insights, digital health funding increased to US$5.3 billion in Q1-'25 – up 47% QoQ and the highest since Q2'22 – as investors concentrate capital on startups with regulatory milestones and scalable AI platforms, like Medsi AI.

Medsi AI's news announcement comes as Mexico's healthcare landscape is undergoing a major transformation:

President Sheinbaum's administration has outlined new initiatives to improve Mexicans' health, with a strong focus on disease prevention, everyday health initiatives, and modernization of healthcare. The Mexican public healthcare system, however, is tasked to "do more, with less" as dramatic budget cuts in public spending further shift the burden to the private sector, which will increase the already high out-of-pocket health spend in Mexico.

Consequently, major Mexican private-sector players like Grupo Salinas are launching affordable health service models – adopting new, disruptive technology solutions – signaling a major shift in how healthcare is being delivered across the country. There appears to be a growing awareness that to tackle the complex and deeply rooted problems that underlie Mexico's current health crisis requires parallel efforts from the public and private sectors, while aggressively embracing the use of disruptive technology solutions to expand and improve care.

Medsi AI is actively working with multiple B2B and B2G distribution channels to bring its technology to Mexicans across the country as quickly as possible to help improve overall public health and patient outcomes:

  • Government and Public Health Agencies: Provides a COFEPRIS-approved, scalable solution that aligns with Mexico's healthcare-transformation initiatives, extends the reach of the country's limited public health resources, and solves some of the most pressing resource-intensive bottlenecks in the system (i.e., personnel, facilities, supplies).
  • Diagnostics Labs & Primary Care Providers: Partnering with hospitals, pharmacy-based health clinics, diagnostics labs and other primary care providers to integrate its platform and technology into their care protocols. The key benefit providing clinicians with comprehensive patient data before consultations and expanding relationships with millions of patients beyond clinics through continuous monitoring.
  • Corporate Health & Wellness Programs: Medsi is already working with leading Mexican employers to incorporate the new platform powered by Medsi AI into their HR initiatives to reduce absenteeism, decrease employee turnover and boost their retention levels.

Medsi AI is targeting a rapidly growing US$46 billion total addressable market (TAM) for primary care and screening. The company is poised to create a private, parallel healthcare ecosystem that addresses the public health system's constraints, and it's well-positioned to become a dominant player in Mexico's healthcare transformation and solve crucial societal challenges.

Key features of Medsi AI's platform include:

  • Vital Signs & Biomarker Monitoring: Provides remote, contactless measurement of more than 20 health and wellness parameters with medical-grade accuracy, including heart rate, blood pressure, respiratory rate, hemoglobin and hemoglobin A1C levels.
  • Comprehensive Health Profiles: Compiles information from vital sign readings, patient medical records, and uploaded lab results to create a complete digital medical file for users.
  • AI-Powered Health Reports: Delivers personalized insights in plain language for patients, explaining medical findings and highlighting potential health risks. For doctors, it provides powerful medical-inference tools, including tentative diagnoses, interactions & polypharmacy reports, specialist referrals and treatment recommendations based on the industry's standards of care.
  • Early Disease Detection: Calculates risk scores for diabetes, hypertension, and cardiovascular conditions, often detecting risk factors before symptoms appear. Identifies all preventive care and early-intervention opportunities.
  • Lifestyle Guidance: Provides users with actionable recommendations for nutrition, fitness, stress management, rest and other lifestyle factors.
  • Follow-up and Regular Monitoring: Recommends personalized long-term treatment plans for patients with NCDs to discuss with their providers and help ensure adherence.
  • Multi-profile Management: Allows families to manage health information for multiple members under a single account.

"What truly sets us apart is how we've combined cutting-edge AI analysis with behavioral science," said Pablo Muñoz de Cote, Chairman of the Board and co-founder of Medsi AI. "Our new AI health platform doesn't just collect data – it translates complex health information into personalized guidance that adapts to users' distinct profiles and motivation patterns, enhancing their long-term adherence to treatment. This ongoing engagement is critical because real health transformation happens between doctor visits, not during them."

For more information or to schedule a demonstration, please visit www.medsi.ai

About Medsi AI

Medsi AI is a Mexican Health 3.0 pioneer headquartered in Mexico City that is driving a fundamental shift from reactive care to proactive health optimization. Its AI-powered platform transforms any computing device with a camera into a sophisticated health-screening system with medical-grade accuracy so users may measure more than 20 vital signs and biomarkers in less than two minutes. With ongoing use, Medsi can detect or manage chronic conditions before they lead to health crises.

Medsi AI is the first to achieve a Class II Software as a Medical Device (SaMD) approval in the Western Hemisphere via COFEPRIS, establishing it as a new leader for digital healthcare solutions. By combining advanced AI analysis with continuous biometric monitoring and behavioral science, Medsi has delivered the next level of healthcare that is preventive, personalized, and participatory.

Media Contact
Chris Knight, Divino Group for Medsi AI, 1 4157869226, [email protected], www.medsi.ai

SOURCE Medsi AI

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Pablo DeCote, Medsi AI Chairman (left) and Manuel Villalvazo, Medsi AI CEO
Pablo DeCote, Medsi AI Chairman (left) and Manuel Villalvazo, Medsi AI CEO
Antonio Merchant, Medsi AI Medical Director (left), Manuel Villalvazo, Medsi AI CEO, and Pablo DeCote, Medsi AI Chairman (right)
Antonio Merchant, Medsi AI Medical Director (left), Manuel Villalvazo, Medsi AI CEO, and Pablo DeCote, Medsi AI Chairman (right)
Well-being Report Powered by Medsi AI
Well-being Report Powered by Medsi AI
Medsi AI rPPG Facial Scan at 0 percent
Medsi AI rPPG Facial Scan at 0 percent
Pablo DeCote, Medsi AI Chairman (left) and Manuel Villalvazo, Medsi AI CEO Antonio Merchant, Medsi AI Medical Director (left), Manuel Villalvazo, Medsi AI CEO, and Pablo DeCote, Medsi AI Chairman (right) Well-being Report Powered by Medsi AI Medsi AI rPPG Facial Scan at 0 percent

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