Company Profile
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Overview
Regulatory status
**Neither the SmarKo device nor any AI algorithm is CE-marked or otherwise certified as a medical device.** Consequences: - Everything we offer is for **research use**. We never claim diagnosis, treatment, clinical accuracy, or use in patient care. - Algorithms produce **estimates for research**, not medical measurements. - Organizations that want to use our technology in routine patient or resident care (e.g. fall detection in a care home) are a fit only through **research studies or pilots**, or as a licensing partner who takes on certification themselves.
Offers
| Offer | Description | Who buys it |
|---|---|---|
| SmarKo® device | Wearable with ECG, EDA, PPG, temperature and environmental sensors; real-time access to **raw** data | Research labs, study teams, project consortia |
| Data platform | Ecosystem to ingest, store and process continuous biosignal data; EU-hosted, GDPR-compliant, end-to-end encrypted, user-controlled data | Labs and companies that need a data pipeline, with or without our device |
| AI algorithms | Estimate measures from raw signals: blood pressure, fall detection, sleep, and more [CONFIRM full list] | Digital health / medtech companies (licensing), research teams |
| Project partnership | Technology partner in funded R&D projects (wearables + data + AI) | EU / national funded consortia |
Ideal Customer Profile
| Segment | Who | Buys | Signals of fit | Priority |
|---|---|---|---|---|
| A | Academic labs using wearables (psychophysiology, stress, sleep, cardiology, sports science, digital phenotyping) | Device + platform | Papers using wrist-worn EDA/PPG/ECG wearables (e.g. Empatica E4/EmbracePlus); grants on remote monitoring | High |
| B | Funded R&D consortia (Horizon Europe, national programs) | Partnership | Open calls on digital health, ageing, AI in health; partner-search listings | High |
| C | Digital health / medtech companies needing algorithms or a white-label wearable | AI licensing, OEM | Products without in-house biosignal AI; hiring for signal processing | Medium |
| D | Elderly care / assisted living providers, insurers | Fall detection, monitoring (research pilots only) | AAL pilots, care digitalisation projects, research partnerships | Medium |
| E | Pharma / CROs (decentralized trials) | Device + platform | DCT announcements, digital endpoint studies | Low: without certification, only exploratory or research-stage studies fit |
Claim rules
- **Medical claims:** allowed wording is "research-grade", "estimates", "for research use". Never "measures blood pressure", "detects falls reliably", "clinically validated", "medical device", or anything implying diagnosis or care use.
- Sender identity, company address and an opt-out line in every outreach email.
- Tone: [CONFIRM — proposed: factual, collegial, researcher-to-researcher; no hype].
Differentiators
- **White-box:** full transparency in how data is collected and processed; raw data, not only derived scores.
- **Customizable end to end:** hardware, software and algorithms can be adapted to a use case.
- **EU data sovereignty:** EU storage, GDPR by design.
- **Proven project partner:** AI-DAPT, COMFORTage, RELEVIUM, DECIDE, ONCORELIEF, STAMINA, 6G-Path, and others.
- **Recognition:** Deutschland – Land der Ideen 1st place (healthcare, 2023), Austrian Blockchain Award 2024, Zuconnect Hackathon 1st place (DeSci, 2023).
Reference competitor
Empatica sells FDA-cleared / CE-MDR wearables and a monitoring platform, mainly to **pharma, CROs, academia and neurology care**. Its customer base is a map of who buys what we sell. Where we differ: raw-data access and white-box processing, EU-hosted data, end-to-end customization, and the flexibility of a small partner. Outreach never disparages or names competitors.