Shen AI's vital signs are now certified: Introducing the Medical SDK
Shen AI now offers a certified Medical SDK under MDR for heart rate, HRV, breathing rate, and blood pressure estimation. Discover how choosing between Shen AI’s Medical and Wellness SDKs helps align your regulatory pathway, clinical validation, and go-to-market timeline.
Shen AI's vital signs are now certified: Introducing the Medical SDK
Shen AI has received certification for its Medical SDK as a CE-marked Class IIa medical device under MDR. This enables organizations to build regulated medical applications using the same camera-based health monitoring technology that powers Shen AI's Wellness SDKs.
The certification covers vital signs estimates for:
- Heart rate
- Heart rate variability (SDNN)
- Breathing rate
- Blood pressure
All within the SDK's approved intended purpose and accompanying medical device documentation.
Why two SDKs, not one
The certified metrics are available through the Medical SDK, which is intended for organizations building regulated medical applications. Unlike our self-service Wellness SDKs, the Medical SDK is provided through a guided onboarding process together with the required medical device documentation. Both SDKs are designed for different product goals and different regulatory pathways.
Choose a Wellness SDK if you're building for health awareness, prevention, employee wellbeing, insurance, or other wellness-focused use cases.
Choose the Medical SDK if you're developing a regulated medical application that requires certified Software as a Medical Device.
Making that call early - before it gets built into your product's claims and user-facing language - helps keep your regulatory strategy, your development effort, and your go-to-market timeline aligned as your product evolves.
See a side-by-side SDK comparison >>>
What this means for you
If you're already building with Shen AI, nothing changes unless you want it to. Your Wellness SDK integration continues to work exactly as it does today.
If you're exploring a use case that touches on regulated medical claims, the Medical SDK gives you that certified level. Remember that the Medical SDK does require a separate integration, as it’s a standalone product.
If you're not sure yet which path fits your roadmap, have a look at this side-by-side comparison of Shen AI SDKs covering intended use, validation, compliance, customization, and licensing.
To learn more about integrating the Medical SDK, contact our Team.
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