Choosing the right Shen AI SDK

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Shen AI offers three SDKs designed for different product strategies and regulatory environments. Although they share the same core technology, they are separate products with different intended uses, feature sets, and compliance considerations.

Choosing the right SDK depends on where your product will be used, the types of health insights you want to provide, and the regulatory framework you need to align with. This guide explains the differences and helps you identify the best fit for your application.

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Three SDKs for different product strategies

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Wellness SDK Global

The Wellness SDK Global is Shen AI's flagship SDK. It offers the broadest set of physiological measurements, wellness insights, and health indices, making it the recommended choice for organizations building wellness and digital health products across multiple markets.

In addition to core vital signs, the Global SDK includes advanced wellness metrics, body composition indices, metabolic estimates, and disease-related health risk indices.

For products serving both US and international users, the Global SDK also supports an optional V3 design mode, providing a General Wellness–aligned user experience while preserving the full feature set.

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General Wellness SDK US

The General Wellness SDK US is a separate SDK designed specifically for products targeting the United States.

It aligns with FDA General Wellness guidance by using wellness-focused terminology and a simplified set of measurements. Disease-related health risk indices are intentionally excluded, helping organizations position their products within a general wellness framework.

Although it shares the same underlying sensing technology as the Global SDK, it requires a separate integration.

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Medical Device SDK

The Medical Device SDK is Shen AI's regulated product for healthcare applications requiring certified physiological measurements.

It is a CE-marked Class IIa medical device under the European Medical Device Regulation (MDR) and is intended for physiological assessment within its approved intended purpose. The certified measurement scope includes:

- Heart Rate
- Heart Rate Variability (SDNN)
- Breathing Rate
- Blood Pressure

Unlike the wellness SDKs, the Medical Device SDK is designed for regulated healthcare environments and requires human oversight before clinical decisions are made.

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SDK comparison

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Feature	Wellness SDK Global	General Wellness SDK US	Medical Device SDK (Anvisa, CE)
Primary positioning	Global wellness platform	Aligned with FDA General Wellness guidelines	Regulated healthcare
Target markets	Global	United States	Brazil (ANVISA) Europe (CE)
Regulatory framework	Wellness	FDA General Wellness	ANVISA Risk Class II medical device software under Classification Rule 11 EU MDR Class IIa medical device software
Primary use	Consumer wellness, digital health, insurance, employee wellbeing	US wellness applications	Clinical and regulated healthcare
Vital signs	From face scan only: Heart rate HRV Breathing rate Blood pressure	From face scan only under wellness-focused naming: Pulse insight Short-term variability insight Breathing rhythm insight BP estimate	From face scan only, certified: Heart rate HRV Breathing rate Blood pressure
Advanced metrics¹	Full set available	??	??
Health indices²	Full set available	??	??
Health risks	Full set available	Not available	??
Terminology	Standard	Wellness-focused	Standard
Blood pressure calibration	Available, optional	??	??
White-label	Available	Available	??
Customization	Available	??	??
PDF reports	Available	??	??
1. Advanced metrics include: Parasympathetic Activity, Stress Index, Cardiac Workload, BMI. 2. Health indices include Wellness Score and body composition & metabolic indices.

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Metric terminology

One of the biggest differences between the Global and US SDKs is how certain measurements are presented.

The underlying physiological signals remain the same, but the General Wellness SDK US uses wellness-oriented terminology that aligns with its intended positioning.

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Wellness SDK Global	General Wellness SDK US
Heart Rate	Pulse Insight
Heart Rate Variability	Short-term Variability Insight
Breathing Rate	Breathing Rhythm Insight
Blood Pressure	BP Estimate
Stress Index	Stress Response Index
Parasympathetic Activity	Parasympathetic Activity Insight
Cardiac Workload	Cardiovascular Effort Index
BMI	Body Mass Score

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Please note: The General Wellness SDK US also includes the Wellness Score and Body Composition & Metabolic indices under standard terminology. Health risk indices are currently only available in the Wellness SDK Global.

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Which SDK should you choose?

The right SDK depends primarily on your product goals and target market.

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Choose Wellness SDK Global if you:

- are building for multiple countries or a global market,
- want the broadest set of wellness insights,
- need health risk indices,
- expect your product to evolve with additional features over time.

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Choose General Wellness SDK US if you:

- are building specifically for the US market,
- want to align with FDA General Wellness guidance.

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Choose Medical Device SDK if you:

- are developing a regulated healthcare product,
- require certified physiological measurements,
- need a medical device intended for clinical or healthcare workflows.

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Good to know

Although all three SDKs are based on the same underlying camera-based sensing technology, they are separate products rather than different operating modes of the same SDK.

If you're unsure which SDK is the best fit for your application, contact the Shen AI team. We'll help you choose the product that matches your market, compliance requirements, and long-term roadmap.

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