| Find your fit |
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| Best for | Products focused on wellness and health awareness | Products marketed under the FDA General Wellness guidance | Medical and clinical applications requiring certified technology |
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| What it is | A wellness SDK for health awareness and lifestyle applications | Software as a medical device (SaMD) for clinical useCE marked under the EU MDR. Registered with ANVISA in Brazil. |
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| What you can tell your users | For informational purposes only. See the disclaimers. | Follow the approved Intended Purpose and IFU (CE, ANVISA). |
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| What you can measure |
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| 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
- Blood pressure (systolic, diastolic)
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| 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 |
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| Health risk indicators | Full set available. See the list. | Not available | Currently not available |
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| Trust and compliance |
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| Validation and accuracy | See the general accuracy results. | Clinically validated against reference measurement methods. Performance characteristics and limitations are provided in the Instructions for Use. |
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| Certification | Not applicable | CE marked under the EU MDR, Class IIaANVISA registered in Brazil, Class II |
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| Compliance documents you receive | Legal guidelines and recommended disclaimers | SLA, Intended Purpose, IFU, technical specifications, approved labelling |
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| Data compliance | Developed under ISO 13485 QMSISO 27001 certified | Developed and maintained under an ISO 13485-certified Quality Management System. ISO/IEC 27001-certified information security management system. |
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| Who is responsible to regulators | You (the application provider) | Shared responsibilities defined in the Medical SDK agreement |
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| Make it your own |
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| White label and branding | White label available in some plansFully customizable | Branding within medical device requirements |
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| 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. |
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| PDF reports | Available and customizable | Not available |
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| User onboarding | Available as part of the full SDK UI | Available as part of the full SDK UI, mandatory |
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| Getting started |
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| Free trial | 30-day free trial. Sign up yourself and test in the Playground in the Shen AI Platform. | 30-day free trial through our team. Playground available in the Shen AI Platform. | Custom setup with guided onboarding |
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| Support | Support centerDedicated Slack channel available on some plans |
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| Updates | Continuous improvements | Controlled, documented changes | Controlled medical device updates |
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