EnsoData, a healthcare technology company, has received FDA clearance for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as aid for the diagnosis of adult sleep and respiratory related sleep disorders.
“FDA clearance of the EnsoSleep technology represents an historic milestone for our company and sleep clinicians who want to realize the huge time savings that are possible with automated analysis of sleep study results,” says Chris Fernandez, EnsoData’s CEO and co-founder, in a release. “It took months of detailed testing and validation of our product by everyone on the EnsoData team, along with our early clinical partners. We’re confident this will be the first of many EnsoData products receiving FDA clearance to power company growth into the future.”
EnsoSleep’s proprietary sleep scoring and event detection algorithms are based on current American Academy of Sleep Medicine (AASM) guidelines. EnsoSleep intelligently automates the recognition and annotation of sleep staging, respiratory events, arousals, and movement events.
EnsoSleep’s software clinical performance was validated in a clinical study with signals acquired from the most popular PSG systems. The results compared automatically detected sleep staging, sleep-disordered breathing, apnea hypopnea index, apneas, obstructive apneas, arousals, and leg movements with scoring results obtained from a majority consensus between several experienced sleep technologists, providing evidence of the clinical performance of EnsoSleep automated sleep scoring that was utilized to support the decision for FDA clearance.
Through user experience testing, EnsoSleep was demonstrated to integrate into existing sleep lab workflows with a HIPAA compliant, cloud-based system designed to automatically upload, analyze, and report study results in a fraction of the time it takes to manually analyze a sleep study, according to the company. To maximize computational throughput and efficiency, EnsoSleep’s cloud system leverages massively parallelized distributed computing and storage optimization to handle terabytes of incoming health data.
EnsoSleep provides extensive interoperability with a variety sleep testing devices and software, interfacing with popular PSG viewing, editing, and reporting tools, supporting the ability to export reports and summaries to the electronic health record.
With the FDA milestone completed, EnsoData is now leveraging algorithmic and Big Data technologies to enable sleep centers and health systems to significantly increase operational efficiency and reduce costs all across the United States.