Philips RS North America LLC has become the first to receive autoscoring software certification from the American Academy of Sleep Medicine (AASM) for its Sleepware G3 with Somnolyzer v4.0.2.0 software.
The AASM launched the autoscoring certification program last year. The program independently evaluates the real-world performance of autoscoring software that provides adult sleep stage scoring from the analysis of data gathered by polysomnography. This evaluation process uses private sleep study data scored by experts in the sleep field. Certification is a demonstration to accredited sleep facilities that the accuracy of an autoscoring solution is comparable to manual scoring by trained professionals.
“I congratulate Philips RS North America LLC for having the first software to be certified through the AASM Autoscoring Certification pilot program,” says AASM executive director Steve Van Hout in a release. “The American Academy of Sleep Medicine is committed to ensuring that technological advances support the provision of high-quality, patient-centered sleep care.”
Data from polysomnograms are “scored” to identify sleep stages and measure physiologic events, which contributes to the definition of certain sleep disorders, assessment of sleep disorder severity, and evaluation of a therapy’s efficacy. The modern sleep disorders center is seeing a shift in how day-to-day tasks are being performed.
Artificial intelligence technology has opened the door for highly accurate autoscoring solutions that will likely play a bigger role in AASM-accredited sleep facilities in the future. While the Food and Drug Administration (FDA) has oversight over many of these solutions, FDA requirements for scoring accuracy lack a formal process for independent verification. Additionally, sleep medicine professionals may feel unsure about available solutions since they are radically different than manual scoring.
The AASM is accepting applications for this pilot program through March 31. To be considered for certification, autoscoring software must have received 510(k) clearance from the FDA, or the company must be in the submission process with the FDA. The software also must be able to analyze raw, unscored, full-night polysomnography records.
Companies that achieve certification receive a certificate and a license to utilize the autoscoring certification mark for promotional purposes. Certified software is also recognized on the AASM website.
For more information about the certification standards, or to request an eligibility checklist, companies can contact the AASM at [email protected].
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