KOSMOS

The KOSMOS system is a diagnostic device designed to empower healthcare professionals with synchronized, multimodal data by integrating ultrasound imaging, electrocardiogram (ECG) rhythms, and digital auscultation (DA) capabilities into a single platform. Its methodology involves a cabled probe with combined sensors and a tablet interface for acquiring, processing, and displaying comprehensive cardiac, pulmonary, and abdominal assessments in adult and pediatric patients.

The KOSMOS system is a diagnostic tool intended for use by qualified healthcare professionals to perform clinical assessments of the cardiac, pulmonary, and abdominal systems in adult and pediatric patients. It operates non-invasively and is reusable, designed for use on one patient at a time in both clinical care and medical education settings. The system comprises a tablet and a cabled probe, along with accessories like a power charger, ECG cable, and binaural headset, supporting operation on battery or mains power. Its core function is to acquire, process, display, measure, and store synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms, facilitating comprehensive patient evaluation. The KOSMOS probe uniquely integrates an ultrasound transducer and sealed microphones for auscultation, while also connecting to a 3-lead single-channel ECG system for capturing Lead I, II, or III waveforms. This integration provides time-synchronized data, offering a holistic view, with ECG serving as a timing reference for cardiac cycle events in relation to ultrasound and auscultation. Its ultrasound capabilities are extensive, encompassing B-mode, M-mode, Color Doppler, combined B+M and B+CD modes, and Harmonic Imaging. These support a range of clinical applications including cardiac, thoracic/lung, abdominal, peripheral vascular assessments, and image guidance for needle/catheter placement. The tablet displays all acquired data, including patient information and reports, and allows user interaction via a touchscreen and buttons, with Wi-Fi for data archival.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the specific design of the integrated probe, housing both ultrasound and auscultation sensors, affect signal quality and potential interference between modalities during concurrent acquisition?; What level of training is recommended for healthcare professionals to effectively utilize and interpret the synchronized data from all three KOSMOS modalities (ultrasound, ECG, DA) for comprehensive patient assessment?; Can the KOSMOS system's digital auscultation differentiate and identify specific pathological sounds (e.g., different types of murmurs or lung crackles) with accuracy comparable to traditional stethoscopes used by experienced clinicians?; Considering its application in image guidance for needle/catheter placement, what are the specific performance characteristics (e.g., spatial resolution, needle visibility enhancements) of the KOSMOS ultrasound component for such procedures?; How does the KOSMOS device's performance in pediatric populations, particularly for cardiac and pulmonary assessments, compare to existing standard-of-care diagnostic tools, given potential differences in patient size and physiology?