Venue Fit

The Venue Fit is a portable, general-purpose diagnostic ultrasound system designed to provide comprehensive imaging and fluid analysis across diverse clinical applications using established ultrasound principles and multiple transducer types. It incorporates AI-assisted nerve detection (cNerve), expanded pediatric capabilities, and various workflow enhancements to improve diagnostic support and usability for healthcare professionals.

The Venue Fit is a general-purpose diagnostic ultrasound system designed for qualified healthcare professionals to perform ultrasound imaging, measurement, display, and analysis of the human body and fluid across a wide spectrum of clinical applications. These applications include abdominal, thoracic/pleural, ophthalmic, fetal/OB, small organ, vascular, neonatal and adult cephalic, pediatric, musculoskeletal, cardiac, transrectal, transvaginal, transesophageal, intraoperative, and interventional guidance. The system's methodology relies on established ultrasound science, employing linear, convex, and phased array transducers to support standard acquisition modes such as B-mode, M-mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, and Harmonic Imaging. It is a compact, portable device featuring a high-resolution color LCD monitor with a multi-touch user interface, capable of battery or outlet power, and supports DICOM for image storage and archiving. This iteration of the Venue Fit introduces several technological enhancements and new features aimed at improving diagnostic capabilities and workflow. Key additions include 'Scribble' for training, 'Power Doppler Imaging+' (PDI+) for visualizing slow blood flows, 'Catheter Vessel Ratio' for guiding catheter selection, 'Probe Check' for automated transducer element verification, and 'Shoulder Diagram' for standardized documentation. A significant advancement is the 'cNerve' AI tool, which aids in detecting and tracking nerves during the scouting phase of nerve block procedures in adults. The system also extends its 'B-lines tool' and 'Real-Time Ejection Fraction' functionalities to pediatric patients (excluding neonates). Non-clinical testing confirmed the device's compliance with safety and performance standards related to acoustic output, biocompatibility, cleaning, and electrical/mechanical safety. Specifically, the cNerve AI was validated against a dataset from 44 individuals (124 sequences), demonstrating accuracy in nerve detection across various demographics and conditions, with a clear separation between training and testing data.

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 performance of the 'cNerve' AI feature compare across different nerve complexities and in patients with varying tissue characteristics not explicitly detailed in the demographic subgroups?; What are the quantitative benefits of the 'Power Doppler Imaging+' (PDI+) feature in terms of sensitivity to slow flow compared to standard Power Doppler on this or predicate devices?; Are there any plans to validate or extend the 'Catheter Vessel Ratio' tool for specific pediatric age groups or critical care scenarios where precise catheter sizing is crucial?; What was the methodology for determining that 'at least 70% of sequences are meaningfully detected' for the cNerve feature, and how was 'meaningfully detected' defined?; Given the expansion of features like B-lines and Real-Time EF to pediatrics, what considerations were made for age-specific anatomical and physiological differences in the algorithm adjustments?