Medsi AI's Platform Approved as Class II Medical Device in Mexico

May 29, 2025
Medsi AI's platform has been approved as the first Class II Software as a Medical Device (SaMD) for preventive health in the Western Hemisphere, according to a press release. This approval by COFEPRIS allows smartphones to be used as medical diagnostic tools.

Medsi AI has announced that its digital health platform has been approved as the first Class II Software as a Medical Device (SaMD) for preventive health in the Western Hemisphere. This approval by COFEPRIS, Mexico's equivalent of the FDA, enables smartphones to function as sophisticated medical diagnostic tools, .

The platform allows users to conduct a 70-second 'video selfie' using any device with a camera, such as a smartphone, to measure over 20 vital signs and biomarkers, including heart rate, blood pressure, and oxygen saturation. This innovation aims to make preventive healthcare more accessible to millions of Mexicans.

Backed by strategic investor Laboratorios Sanfer, Medsi AI has secured USD $3 million in Seed 1 funding to accelerate its mission of transforming healthcare in Mexico. The platform is designed to detect early signs of chronic conditions like diabetes and hypertension, allowing for timely intervention.

Medsi AI is collaborating with government agencies, healthcare providers, and corporations to integrate its technology into existing healthcare systems, aiming to improve public health outcomes across Mexico.

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