​SleepImage announces FDA-clearance for Photoplethysmogram (PPG) data input for Cardiopulmonary Coupling analysis and Apnea Hypopnea Index (sAHI) for Diagnosing Sleep Disordered Breathing.


SleepImage
October 17, 2019

SleepImage® proudly announces new functionality to its clinically validated, FDA-cleared SleepImage System Software as a Medical Device (SaMD).
 
This new FDA-clearance adds:
1. A photoplethysmogram (PPG) sensor input to obtain the optical plethysmogram (PLETH) signal as an alternative input to the previously cleared electrocardiogram (ECG) signal for the SleepImage System Cardiopulmonary Coupling analysis.
2. SleepImage Apnea Hypopnea Index (sAHI) is automatically calculated from SpO2 input data to categorize sleep disordered breathing (SDB) in children and adults adhering to American Academy of Sleep Medicine (AASM) guidelines and thresholds to aid clinical diagnosis of SDB.
 
This latest innovation is based on years of research and clinical validation that makes the SleepImage System flexible like no other clinical sleep diagnostic and management system to provide actionable information, associated with health outcomes.
 
The Value of SleepImage for Sleep Apnea Diagnosis is Unmatched:
The SleepImage System is cleared to analyze data from ECG and PPG hardware devices that meet defined acquisition characteristics, offering value unmatched by any other sleep diagnostic device.
 
The Introductory Offer of SleepImage is Unmatched:
The first hardware device to be launched based on this new clearance is Nonin 3150 BLE, which is commonly used as part of other sleep diagnostic devices for recordings of PLETH and SpO2 data.
 
1. For a limited time, get 100 report credits for the price of 50 report credits with the purchase of a Nonin 3150 BLE. For an investment of $1,549.50 we deliver report credits worth $1,499 making the investment in the hardware equivalent to only $50.50.
2. For a limited time, the SleepImage Report with the SleepImage Apnea Hypopnea Index (sAHI) is offered for 2 report credits ($29.98) instead of 3 report credits ($44.97).
3. The SleepImage Report without sAHI continues to be offered for only 1 report credit ($14.99), which on its own is ideal for screening or therapy tracking purposes.
 
The Flexibility of SleepImage is Unmatched:
1. SleepImage has the only FDA-cleared measurement of sleep quality, the Sleep Quality Index (SQI), to track sleep health over time.
2. SleepImage is the only FDA-cleared diagnostic test for sleep disordered breathing (SDB) that offers software generated information on oxygen desaturations (sAHI) and cardiovascular reaction to paused breathing (SAI), providing a comprehensive severity measure of SDB.
3. SleepImage is the only FDA-cleared diagnostic test for SDB in children that can be performed in the child’s home, with an AHI output that is comparable to manual scoring of AHI from PSG.
 
The Usability of SleepImage is Unmatched:
The SleepImage System with SpO2 meets current technical and output requirements used by other sleep diagnostic devices for sleep apnea reimbursement and to prescribe therapy. Decisions for coverage are pending insurance approvals and may differ between providers. SleepImage is a diagnostic solution, FDA cleared for use in both children and adults, intended for use in patients’ homes.
 
1. SleepImage is the only sleep diagnostic device that only requires a single sensor to produce diagnostic output for sleep apnea that is FDA-cleared to be comparable to manual scoring of in laboratory conducted PSG studies.
2. SleepImage is the only FDA-cleared sleep diagnostic device other than PSG that measures sleep time directly from sleep physiology, not requiring an accelerometer or other sensors to estimate sleep time.
3. SleepImage is the only FDA-cleared sleep diagnostic device that is cleared for both asymptomatic and symptomatic patients, making it useful to screen patients for sleep disorders prior to initiating any treatment.
4. SleepImage is the only FDA-cleared sleep diagnostic device that is cleared to manage sleep disorders. Using objective information on sleep quality and sleep apnea makes SleepImage useful to manage sleep disorder interventions over time, similar to how information from blood pressure monitoring is used to manage care for hypertensive patients.
 
The SleepImage System has been vigorously validated in clinical research. Detailed results of the validation process that led to this FDA-clearance is presented in our Introduction to SleepImage.
 
The SleepImage Team
Contact: Bogi Palsson 970-445-7252, bogi.palsson@sleepimage.com
Sales: sales@sleepimage.com