Shen AI Vitals receives ANVISA approval as a class II medical device in Brazil

Shen AI Vitals has officially received ANVISA approval. This marks a major milestone in our mission to deliver clinically trusted, contactless health insights across digital health, insurance, and telemedicine platforms.

ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil’s National Health Surveillance Agency and one of the most respected regulatory bodies in Latin America. Its approval of Shen AI Vitals confirms that our technology meets the safety, performance, and regulatory requirements for use in Brazil’s healthcare ecosystem.

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What ANVISA approval involves

Shen AI Vitals is registered with ANVISA under approval number 81464750186 under RDC 751/2022 as a class II medical device under rule 11 (software that monitors physiological functions) for mobile and web deployment. 

All signal processing and metric extraction are performed locally on the user’s device, ensuring compliance with relevant privacy standards.

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Enabling faster integration in regulated LATAM markets

With ANVISA approval in place, Shen.AI Vitals is now available for integration into regulated digital health solutions across Brazil. This enables developers, healthcare providers, and insurers to:

• Confidently integrate contactless, clinically validated health monitoring into their platforms
  
  
• Streamline compliance for solutions involving physiological measurements
  
  
• Accelerate development cycles and reduce regulatory complexity
  
  
• Offer real-time health insights to broader populations without requiring wearables or external hardware
  
  

This opens the door to new use cases in teleconsultation, chronic care, remote triage, and digital wellness, all powered by a face scan with a standard device camera.

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What Shen.AI Vitals measures

Shen AI Vitals provides real-time estimates of heart rate and heart rate variability (HRV) as well as respiratory rate with contactless, camera-based measurements. The health metrics are derived using remote photoplethysmography (rPPG) - with no need for wearables or external sensors.

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See what’s possible with Shen AI Vitals

With ANVISA approval, Shen AI Vitals is now part of the regulated digital health landscape in Brazil. If you're exploring ways to bring real-time, camera-based health insights into your product -without adding hardware or complexity - we’d love to show you how it works.

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Schedule a demo and see how it could fit into your roadmap.

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