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

Swipe to compare all three SDKs →

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