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Last updated: June 5, 2026
Back to directoryEko Health SENSORA medical AI product profile
FDA-cleared cardiovascular detection platform that pairs Eko digital stethoscopes with AI-supported ECG and heart-sound analysis for supervised point-of-care screening.
Precision medicine and data
Best fit
Health systems and clinics that want to add clinician-reviewed cardiac disease detection signals to routine intake, primary care, or outpatient cardiovascular screening workflows.
- Primary use case
- FDA-cleared AI analysis of ECG and heart sounds from compatible Eko digital stethoscopes to flag atrial fibrillation, structural murmurs, low ejection fraction signals, and normal sinus rhythm for clinician review
- Audience
- Primary care, cardiology, health-system screening programs, outpatient clinics, and enterprise teams evaluating digital stethoscope AI
- Risk level
- High
- Pricing signal
- Enterprise annual SENSORA licensing; request current device, software, reimbursement, integration, training, and regional availability terms.
- Official sources
- 6 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Eko Health SENSORA as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated cardiac detection support tied to specific Eko devices, algorithms, adult-use labeling, and FDA-cleared indications; do not generalize one algorithm clearance to unsupported arrhythmias, pediatric workflows, diagnosis, or treatment decisions. |
|---|---|
| Privacy | Review ECG, phonocardiogram, audio, patient identifier, app, dashboard, EHR, support, and analytics data flows, plus BAA, HIPAA, encryption, access control, retention, deletion, and secondary-use terms. |
| Evidence | Check FDA records, Eko's clinical-study references, algorithm-specific validation, acquisition protocol, patient mix, structural murmur and AFib performance, low-EF evidence, false-positive burden, and whether results match local screening goals. |
| Workflow | Best governed as clinician-reviewed point-of-care cardiac screening support with trained acquisition staff, documented provider over-read, clear referral thresholds, conventional diagnostic backup, and monitoring for over-referral or missed disease. |
Where Eko Health SENSORA fits
Eko describes SENSORA as an FDA-cleared enterprise cardiovascular detection platform that integrates with Eko digital stethoscopes and analyzes heart sounds and ECG to help clinicians identify signs of atrial fibrillation, structural murmur, low ejection fraction, and normal sinus rhythm; Eko regulatory, security, privacy, and FDA-clearance materials describe product clearances, adult-use and physician-review boundaries, encryption, HIPAA handling, and the EFAST algorithm clearance.
Not for: Consumer self-diagnosis, pediatric use, autonomous cardiac diagnosis, emergency triage without standard protocols, or use outside compatible devices, labeling, geography, and documented physician review.
What to verify before using Eko Health SENSORA
- Which SENSORA algorithm, device, software version, compatible stethoscope, patient population, geography, and FDA-cleared indication are in scope.
- Whether the workflow analyzes ECG, phonocardiogram, murmur timing, atrial fibrillation, normal sinus rhythm, low ejection fraction, or a combination of supported outputs.
- How recordings, ECG traces, patient identifiers, Eko app or dashboard data, EHR customization, support access, retention, encryption, BAA, and HIPAA terms are handled under contract.
- Local performance for intake staff acquisition, failed recordings, false positives, missed findings, cardiology referrals, provider over-read, CPT documentation, and post-deployment monitoring.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.ekohealth.com / pages / sensora
- www.ekohealth.com / blogs / newsroom
- support.ekohealth.com / hc / en-us
- support.ekohealth.com / hc / en-us
- support.ekohealth.com / hc / en-us
- www.accessdata.fda.gov / cdrh_docs / pdf21
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