FDA-Cleared AI-Powered Sleep Diagnostics
Our integrated technology platform combines industry-leading hardware, sophisticated AI algorithms, and intuitive software to deliver accurate, efficient sleep apnea diagnosis.
CheckMe O2 Max
Comfortable wrist-worn pulse oximeter by Viatom Technology. Records SpO2, heart rate, and motion for 3 consecutive nights.
- 16+ hours recording capacity
- Wrist-worn comfort
- Bluetooth sync via app
- FDA 510(k) cleared
EnsoData AI
FDA-cleared AI scoring platform trained on over 1 million polysomnograms. Delivers 94% sensitivity for moderate-severe OSA.
- 94% sensitivity, 96% specificity
- True Sleep Time calculation
- Multi-night aggregation
- Equity-validated algorithms
SleepDx Platform
HIPAA-compliant practice management system built on Microsoft Azure. Manages the entire workflow from enrollment to reporting.
- Device tracking & logistics
- Automated patient emails
- Real-time status updates
- Billing & reporting
How It Works
A seamless workflow from patient enrollment to final report delivery.
Patient Enrollment
Practice staff enters patient demographics and clinical indication. Device is either dispensed in-office or shipped directly to patient via Impilo Health fulfillment.
- EHR integration available
- Automated shipping labels
- Patient receives instruction email
3-Night Home Recording
Patient wears the CheckMe O2 Max device on their wrist for 3 consecutive nights. The Celeste+ smartphone app guides setup and automatically uploads data each morning.
- Captures SpO2, heart rate, motion
- Smartphone microphone adds acoustic analysis
- Real-time sync verification
AI-Powered Scoring
EnsoData's FDA-cleared algorithms analyze the data, detecting respiratory events with 94% sensitivity. The AI calculates true Total Sleep Time—not just recording time.
- Multi-night data aggregation
- AHI, ODI, TST metrics
- Sleep staging from pulse oximetry
Physician Interpretation
Board-certified sleep physician reviews the AI-generated results and provides expert interpretation. Final report is delivered to your portal within 48-72 hours.
- Board Certified Sleep Specialist interpreters
- Multi-state licensed coverage
- Actionable clinical recommendations
Clinical-Grade Results
EnsoData AI provides comprehensive metrics that go beyond traditional home sleep testing.
Number of apnea and hypopnea events per hour of sleep. The primary diagnostic metric for OSA severity.
Number of oxygen desaturation events (≥3%) per hour. Correlates with cardiovascular risk.
Actual time spent sleeping, not just recording time. Critical for accurate AHI calculation.
Blood oxygen levels throughout the night. Low nadir values indicate severe respiratory events.
Additional Analysis Features
Sleep Staging
EnsoData AI differentiates between wake, light sleep, deep sleep, and REM sleep using pulse oximetry data alone. Over 90% accuracy compared to polysomnography.
Snoring Analysis
Smartphone microphone captures audio during sleep. AI quantifies snoring frequency and intensity, providing insight into upper airway dynamics.
Night-to-Night Variability
3-night protocol captures the natural variability in sleep patterns. Prevents the 10% misclassification rate seen with single-night testing.
AI Performance You Can Trust
EnsoData's algorithms were trained on over 1 million diagnostic polysomnograms, making them among the most thoroughly validated AI systems in sleep medicine. Independent clinical studies have documented exceptional performance.
Equity in Diagnosis
EnsoData has proactively validated their AI system for equitable performance across diverse patient populations. A study presented at SLEEP 2024 evaluated 215 subjects with standardized skin color assessments.
Security & Compliance
Built on enterprise-grade infrastructure with healthcare-specific compliance.
HIPAA Compliant
Full HIPAA compliance with BAAs for all technology partners
Azure Healthcare Cloud
Built on Microsoft Azure's healthcare-compliant infrastructure
Encryption
AES-256 at rest, TLS 1.3 in transit
FDA Cleared
All diagnostic components are FDA 510(k) cleared
Experience the Technology
See how our AI-powered platform can transform sleep apnea diagnosis in your practice.