Kosmos
EchoNous, Inc.Kosmos is a handheld diagnostic ultrasound system combined with ECG and digital auscultation capabilities. It helps healthcare professionals perform clinical assessments across multiple body regions such as cardiac, thoracic, abdominal, vascular, and musculoskeletal areas by providing synchronized ultrasound images, ECG rhythms, and auscultation sounds. The device supports various ultrasound modes including B-mode, Doppler, and harmonic imaging, enhancing diagnostic capabilities in a single portable platform.
Intended Use
Kosmos is intended to be used by qualified and trained healthcare professionals in clinical assessment via ultrasound imaging, synchronized ECG rhythms, and digital auscultation sounds across cardiac, thoracic/lung, abdominal, vascular, musculoskeletal, and interventional guidance applications.
Technology
Kosmos combines a tablet and probe system. The probe houses an ultrasound transducer and sealed microphones for auscultation, integrating ultrasound imaging, ECG, and digital auscultation in a time-synchronized manner. The system supports multiple ultrasound modes (B-mode, Doppler, M-mode, harmonic imaging), uses a 3-lead single-channel ECG, and digital auscultation with digital signal processing. Connectivity options include Wi-Fi for data transfer and software updates, while operating on mains or battery power.
Performance
Kosmos underwent non-clinical performance testing to meet FDA-recognized consensus standards including electrical safety (IEC 60601 series), ultrasonic performance (IEC 60601-2-37, IEC 62359), biomedical evaluation (ISO 10993-1), software lifecycle (IEC 62304), usability (IEC 62366-1), and others. Verification and validation confirmed it meets specifications and is substantially equivalent to predicate devices. Clinical performance data was not required.
Predicate Devices
No predicate devices specified
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