Verification evidence is still being completed.
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Bone Index Finland Ltd.
Kuopio, Finland
- Verified lead
- Janne Karjalainen
- Lead status
- STATUS: VERIFIED APRIL 2026
- Leadership verification
- Chief Executive Officer
- 2026 technical specialization
- Point-of-Care Pulse-Echo Ultrasound, Osteoporosis Diagnosis, and Bone Density Testing
- Review cycle
- 24 April 2026
- Full address
- Savilahdentie 14, 70700 Kuopio, Finland
- Site coordinates
- Verification evidence is still being completed.
- Editorial review
- Memel Biotech editorial review
- Official leadership source
- Bone Index LinkedIn company page listing Janne Karjalainen as CEO.
- Editorial note
- Kuopio point-of-care osteoporosis diagnostic developer with named CEO, FDA 510(k) clearance, CE MDR marking, and a 2024 financing round.
Point-of-Care Pulse-Echo Ultrasound, Osteoporosis Diagnosis, and Bone Density Testing
FDA 510(k) clearance, CE MDR, ISO 13485 presumed for device manufacture
Kuopio point-of-care osteoporosis diagnostic developer with named CEO, FDA 510(k) clearance, CE MDR marking, and a 2024 financing round.
Review coverage
Leadership
Facility
Certifications
Capabilities
Partners
Sources
Quality
Editorial verificationMemel Biotech directory review sign-off
Report generated02 Jun 2026, 01:40
Company profile · Kuopio, Finland
Bone Index Finland Ltd.
Point-of-Care Pulse-Echo Ultrasound, Osteoporosis Diagnosis, and Bone Density Testing · Medical-device manufacturing
Kuopio point-of-care osteoporosis diagnostic developer with named CEO, FDA 510(k) clearance, CE MDR marking, and a 2024 financing round.
- Lead
- Janne Karjalainen (verified ↗)
- Address
- Savilahdentie 14, 70700 Kuopio, Finland (source ↗)
- Compliance
- FDA 510(k) clearance · CE MDR · ISO 13485 presumed for device manufacture
- Last reviewed
- 24 Apr 2026 (1mo ago)
- Scale
- Medical-device manufacturing
- Capabilities
- Point-of-Care Ultrasound R&D · Bone Density Algorithm Development · EU and US Commercialization
- Founded
- 2011
- Headcount
- 1-10
- Company page (open ↗)
Clinical profileSTATUS: VERIFIED APRIL 2026
Janne Karjalainen
Chief Executive Officer
Full addressSavilahdentie 14, 70700 Kuopio, Finland
Site coordinatesVerification evidence is still being completed.
Review cycle24 April 2026
Physical site source
RocketReach corporate record for Bone Index Finland Ltd. at Savilahdentie 14, Kuopio.
Open sourceMedical-device manufacturing
Kuopio, Finland. Point-of-Care Pulse-Echo Ultrasound, Osteoporosis Diagnosis, and Bone Density Testing. Review completed on 24 Apr 2026.
Fimea and FDA for medical-device oversight
FDA 510(k) clearance, CE MDR, ISO 13485 presumed for device manufacture
Point-of-Care Pulse-Echo Ultrasound, Osteoporosis Diagnosis, and Bone Density Testing
Kuopio point-of-care osteoporosis diagnostic developer with named CEO, FDA 510(k) clearance, CE MDR marking, and a 2024 financing round.
Editorial note
Bone Index is a Kuopio diagnostic medical-device company with a named CEO, FDA 510(k) clearance, and CE MDR marking, plus a 2024 financing round on record.
FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleApril 2026
Capabilities
Core capabilities
Primary declared technical activities and areas of operating focus.
Point-of-Care Ultrasound R&D
Bone Density Algorithm Development
EU and US Commercialization
Verification source dossier
Verification source dossier
Official source set used to support leadership, physical-site, certification, and watch-note evidence.
Infrastructure
Declared infrastructure
Bindex point-of-care ultrasound device
Algorithm development
Clinical validation
Regulatory posture
Quality system coverage
GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.
- GMP
- REVIEW IN PROGRESS 2026
- GLP
- REVIEW IN PROGRESS 2026
- ISO-13485
- VERIFIED ACTIVE 2026
- FDA-Inspected
- VERIFIED ACTIVE 2026
Verification history
Verification history
24 Apr 2026: Executive identity confirmed via official management disclosure.
24 Apr 2026: Full trust review completed.
FAQ
Frequently asked questions
- Where is Bone Index Finland Ltd. located?
- Bone Index Finland Ltd. operates from Savilahdentie 14, 70700 Kuopio, Finland, Kuopio, Finland.
- Who runs Bone Index Finland Ltd.?
- Bone Index Finland Ltd. is led by Janne Karjalainen, Chief Executive Officer. Verified 24 Apr 2026.
- What certifications does Bone Index Finland Ltd. hold?
- Bone Index Finland Ltd. is documented under FDA 510(k) clearance, CE MDR, ISO 13485 presumed for device manufacture.
- What does Bone Index Finland Ltd. do?
- Kuopio point-of-care osteoporosis diagnostic developer with named CEO, FDA 510(k) clearance, CE MDR marking, and a 2024 financing round. Core capabilities: Point-of-Care Ultrasound R&D, Bone Density Algorithm Development, EU and US Commercialization.
Editorial context
Related technical briefs
Briefs that name Kuopio as a covered market or city.