SleepImage

FDA-cleared Software as a Medical Device for diagnosis and management of sleep disordered breathing.

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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)

Home sleep apnea testing (HSAT) Pediatric sleep apnea diagnosis Remote patient monitoring for sleep disorders Longitudinal tracking of sleep quality on therapy

✅ 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

ResMed AirView EnsoSleep Traditional HSAT devices

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

Web iOS Android

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ FDA Cleared (SaMD)

💰 Pricing

Contact for pricing
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