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Ann: Somfit FDA cleared for USA market, page-17

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  1. 223 Posts.
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    Somfit seem to measure more things. Note below may not be correct but was just what I found online so please take with grain of salt.
    Worthy though of more investigation regarding competitors. Apparently the the gold standard is polysomnography (PSG) and only Somfit seems to quote a % correlation.
    FeatureSomfitagainst the gold standard of polysomnography (PSG)Itamar WatchPAT OneApneaLink Air
    TypeWearable HSATPortable HSATWrist-worn HSATCompact HSAT
    Data CollectionEEG/EOG, PAT, SpO2, pulse rate, snoringMulti-channel physiological dataPAT, SpO2, heart rateAirflow, SpO2
    Ease of UseLight, comfortable, mobile app controlRequires trained personnelUser-friendlyMinimal setup
    Regulatory ApprovalYes (FDA cleared)Yes (FDA cleared)Yes (FDA cleared)Yes (FDA cleared)
    Primary UseHome testing and clinical studiesClinical & home useHome useHome use
    Unique FeaturesForehead-worn with EEG capabilityMulti-sensor approachWrist-worn design with PAT technologyNasal cannula technology
    Cost-EffectivenessLower cost per studyHigher initial setup costsCost-effective for home testingAffordable for home testing

    DeviceAgreement with PSGKappa StatisticKey Features
    Somfit76.14%0.672Forehead-worn EEG + PAT
    Philips Respironics AliceNot specifiedNot specifiedMulti-channel physiological data
    Itamar WatchPAT OneHigh correlationNot specifiedWrist-worn with PAT technology
    ApneaLink AirLimited detailsNot specifiedCompact design for airflow

 
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