Mexico City startup, Medsi AI, achieves first SaMD regulatory approval in the Western Hemisphere for its AI-powered diagnostic software.
Utilizing smartphones, the AI software measures over 20 vital signs with medical-grade accuracy to detect health issues like hypertension early.
The AI analyzes vital signs, cross-references medical literature, and generates personalized health insights akin to a medical specialist.
Medsi AI became the first company in the Western Hemisphere to secure Class II SaMD approval, addressing Mexico's chronic disease epidemics.
Mexico's healthcare crisis, exacerbated by dietary changes post-NAFTA, includes high rates of diabetes, hypertension, and inadequate healthcare coverage.
The AI technology interprets health metrics with the sophistication of medical specialists, making early detection and personalized care possible.
Clinical trials and pilot programs in Mexico have shown improved health outcomes with sustained user engagement and significant health marker improvements.
Medsi's AI technology attracted $3 million Seed 1 funding round led by Laboratorios Sanfer, indicating market validation and strategic investment.
The regulatory breakthrough with SaMD approval opens new possibilities for smartphone-based healthcare solutions, enhancing traditional healthcare.
Medsi AI's approach exemplifies Health 3.0, where AI amplifies human medical expertise to democratize access to preventive care.