KI im Gesundheitswesen
July 31, 2026
4 min read

Shen AI SDK comparison: Wellness, General Wellness US, and Medical

Choosing the right SDK is crucial for aligning your product’s regulatory pathway, claims, customization, and go-to-market timeline. Explore this breakdown comparing Shen AI’s three camera-based health monitoring SDK options.

Shen AI now comes in 3 SDK options, each built for a different product goal and regulatory pathway: the Wellness SDK (Global), the General Wellness SDK (US), and the Medical SDK (CE, ANVISA). All three are powered by the same camera-based health monitoring technology - the difference lies in what you're allowed to claim, measure, and build with it.

Here's a full breakdown of what sets them apart, so you can match the SDK to your product.

Find your fit

The right starting point depends entirely on what you're building:

- Wellness SDK (Global) is best for products focused on wellness and health awareness.
- General Wellness SDK (US)
is designed for products marketed under the FDA General Wellness guidance.
- Medical SDK (CE, ANVISA)
is built for medical and clinical applications that require certified technology.

The regulatory pathway shows up most directly in your product's language. With the Wellness and General Wellness SDKs, results are for informational purposes only, and your user-facing copy needs to reflect that. With the Medical SDK, your product claims and instructions need to follow the approved Intended Purpose and IFU exactly as certified. See the below table for more details.

Wellness SDK (Global) General Wellness SDK (US) Medical SDK (CE, ANVISA)
Best for Products focused on wellness and health awareness Products marketed under the FDA General Wellness guidance Medical and clinical applications requiring certified technology
What it is A wellness SDK for health awareness and lifestyle applications A wellness SDK aligned with General Wellness guidance for the US market Software as a medical device (SaMD) for clinical use
  • CE-marked under the EU MDR
  • Registered with ANVISA in Brazil
User messaging For informational purposes only. See Disclaimers . For informational purposes only. See Disclaimers . Follow the approved Intended Purpose and IFU (CE, ANVISA).

What you can measure

All three SDKs estimate vital signs from a face scan alone, without any additional equipment. 

Shen AI vital signs include:

- heart rate
- heart rate variability (SDNN)
- breathing rate
- blood pressure (systolic and diastolic)

All 4 parameters are available across all SDK options. Please mind: medical device (Medical SDK) is subject to controlled changes and is not an exact counterpart of the Wellness SDK Global. General Wellness SDK US uses FDA-aligned terminology: pulse insight, short-term variability insight, breathing rhythm insight, and BP estimate.

The Wellness SDK goes further with stress index, parasympathetic activity, cardiac workload, BMI, and a more complex wellness score. The General Wellness SDK offers a comparable set under FDA-aligned terminology (see table below to compare). Additional metrics, along with the full set of health risk indicators, are currently not available in the Medical SDK, which is scoped to its certified parameters.

Wellness SDK (Global) General Wellness SDK (US) Medical SDK (CE, ANVISA)
Vital signs - from face scan only
  • Heart rate
  • Heart rate variability
  • Breathing rate
  • Blood pressure
Under FDA-aligned terminology:
  • Pulse insight
  • Short-term variability insight
  • Breathing rhythm insight
  • BP estimate
Certified physiological parameters:
  • Heart rate
  • Heart rate variability
  • Breathing rate
  • BP (Systolic blood pressure, Diastolic blood pressure)
Additional metrics
  • Stress index
  • Parasympathetic activity
  • Cardiac workload
  • BMI
  • Wellness score
  • Body composition & metabolic indices
Under FDA-aligned terminology:
  • Stress response index
  • Parasympathetic activity insight
  • Cardiac effort index
  • Body mass score

Under standard terminology:
  • Wellness score
  • Body composition & metabolic indices
Currently not available
Health risk indicators Full set available – see list here. Not available Currently not available

Trust and compliance

Every SDK is backed by clinical validation and developed under rigorous quality and security frameworks. However, the depth of certification, documentation, and regulatory responsibility scales directly with your chosen product option, as outlined below.

Wellness SDK (Global) General Wellness SDK (US) Medical SDK (CE, ANVISA)
Validation and accuracy See general accuracy results here. See general accuracy results here. Clinically validated against reference measurement methods. Performance characteristics and limitations are provided in the Instructions for Use.
Certification Not applicable Not applicable
  • CE-marked under the EU MDR, Class IIa
  • ANVISA registered in Brazil, Class II
Compliance documents you receive Legal guidelines & recommended disclaimers. Legal guidelines & recommended disclaimers. SLA, Intended Purpose, IFU, Technical Specifications, approved labelling
Data compliance Developed under ISO 13485 QMS

ISO 27001 certified
Developed under ISO 13485 QMS

ISO 27001 certified
Developed and maintained under an ISO 13485-certified Quality Management System. ISO/IEC 27001-certified information security management system.
Who is responsible to regulators You (the application provider) You (the application provider) Shared responsibilities defined in the Medical SDK agreement

Make it your own

Every Shen AISDK  option offers flexible integration capabilities, but the level of design freedom and configuration control varies between the wellness and medical tiers. While the Wellness and General Wellness SDKs provide full white-labeling and extensive UI customization to match your product experience, branding and layout changes for the Medical SDK must remain strictly within approved medical device requirements and undergo prior regulatory review.

Wellness SDK (Global) General Wellness SDK (US) Medical SDK (CE, ANVISA)
White-label and branding White label available in some plans

Fully customizable
White label available in some plans

Fully customizable
Branding within medical device requirements
Customization Different levels to choose from:
  • Full SDK UI
  • SDK camera view with app UI
  • Fully custom UI
Different levels to choose from:
  • Full SDK UI
  • SDK camera view with app UI
  • Fully custom UI
Customization is limited to configurations assessed and approved by Shen AI. Changes affecting the user interface, measurement workflow, instructions, results presentation, intended purpose, or regulated functionality require prior regulatory and quality review.
PDF reports Available & customizable Available & customizable Not available
User onboarding Available as part of the full SDK UI Available as part of the full SDK UI Available as part of the full SDK UI, mandatory

Getting started

The Wellness and General Wellness SDKs offer a 30-day free trial. If you’re choosing the Wellness Global version, you can create a Shen AI account yourself and gain instant access to the Shen AI Platform with all tools required for integration readily available inside. To start your trial of the General Wellness (US) SDK or set up your Medical SDK integration, get in touch with our Team.

Wellness SDK (Global) General Wellness SDK (US) Medical SDK (CE, ANVISA)
Free trial and sandbox 30 days free trial

Playground available in the Shen AI Platform
30 days free trial

Playground available in the Shen AI Platform
Custom setup
Support Support center

Dedicated Slack channel available on some plans
Support center

Dedicated Slack channel available on some plans
Support center

Dedicated Slack channel available on some plans
Updates Continuous improvements Controlled, documented changes Controlled medical device updates

Which one is right for you?

There's no universally "better" SDK here, just the one that matches your product's intended use and regulatory pathway. If you're building for health awareness, prevention, or lifestyle guidance, a Wellness SDK is likely your fit. If you're developing a regulated medical application, the Medical SDK gives you a CE-marked, ANVISA-registered foundation to build on.

Not sure which one fits your roadmap? Get in touch with our team - we're happy to walk through your use case and help you find the right starting point.

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