SDKs comparison

Choose SDK that fits your business needs

Shen AI offers three SDK options, each built for a different product goal and regulatory pathway. Use this comparison to find the right fit for your application, whether you are building for wellness and health awareness, developing under FDA General Wellness guidance, or bringing a certified medical device to market.

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 Software as a medical device (SaMD) for clinical use
  • CE marked under the EU MDR
  • Registered with ANVISA in Brazil
What you can tell your users For informational purposes only. See Disclaimers. Follow the approved Intended Purpose and IFU (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 and 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 and metabolic indices
 Currently not available
Health risk indicators Full set available. See the list. Not available Currently not available
Validation and accuracy 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 CE marked under the EU MDR, Class IIa ANVISA registered in Brazil, Class II
Compliance documents you receive Legal guidelines and recommended disclaimers SLA, Intended purpose, IFU, Technical specifications, approved labelling
Data compliance 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) Shared responsibilities defined in the Medical SDK agreement
White-label and branding 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
 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 and customizable Not available
User onboarding Available as part of the full SDK UI Available as part of the full SDK UI, mandatory
Support Support center Dedicated Slack channel available on some plans
Updates Continuous improvements Controlled, documented changes Controlled medical device updates

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