SleepImage
FDA-cleared Software as a Medical Device for diagnosis and management of sleep disordered breathing.
Overview
SleepImage is an FDA-cleared Software as a Medical Device (SaMD) that provides a diagnostic and management tool for sleep quality and sleep apnea. It uses data from a single photoplethysmogram (PPG) sensor, typically a pulse oximeter, which is uploaded from a patient's mobile device. The system automatically analyzes the data and generates a report for clinician review, with outputs comparable to Polysomnography (PSG) for sleep apnea diagnosis.
✨ Key Features
- FDA-cleared for children (age 2+) and adults
- Diagnoses sleep-disordered breathing
- Analyzes sleep quality and stability
- Cloud-based platform with secure clinical portal
- Automatic data analysis and report generation
- Uses data from a single PPG sensor
- Remote patient monitoring capabilities
🎯 Key Differentiators
- FDA clearance for pediatric use (age 2+)
- Focus on sleep quality and autonomic nervous system function, not just AHI
- Simple, single-sensor data acquisition process
Unique Value: Provides an easy-to-use, FDA-cleared method for diagnosing sleep apnea and evaluating sleep quality in both children and adults using a single sensor, enabling broader access to sleep testing.
🎯 Use Cases (4)
✅ Best For
- Primary care and specialty clinics for sleep apnea screening and diagnosis
- Dental sleep medicine
- Pediatric sleep medicine
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Diagnosis of complex parasomnias or seizure disorders requiring full EEG
🏆 Alternatives
Offers a simpler, less invasive testing process than traditional multi-channel HSAT devices and provides unique metrics on sleep quality beyond the standard Apnea-Hypopnea Index (AHI).
💻 Platforms
🛟 Support Options
- ✓ Email Support
- ✓ Phone Support
🔒 Compliance & Security
💰 Pricing
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