Venue Go

The Venue Go is a portable, multi-functional diagnostic ultrasound system that employs ultrasonic pulsed doppler and echo imaging technologies for a wide array of clinical applications, including interventional guidance. It enhances diagnostic capabilities and user workflow through an intuitive multi-touch interface, specialized imaging modes like Power Doppler Imaging+, and an AI-powered cNerve tool for nerve detection.

The Venue Go 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 flow. This compact, portable system features a high-resolution color LCD monitor with a multi-touch user interface, an integrated handle, and can be wall-mounted or placed on a cart. It operates via wall outlet or internal battery, utilizes various linear, convex, and phased array transducers, and supports standard acquisition modes, including biopsy kit compatibility for needle-guidance procedures. The system can display ECG traces synchronized with scanned images for gating purposes (not for monitoring or diagnosis) and includes features like a barcode reader, RFID scanner, wireless communication for DICOM image storage/archiving, and electronic user documentation. The Venue Go provides a broad range of clinical applications such as abdominal, thoracic/pleural, ophthalmic, fetal/OB, small organs, vascular, pediatric, musculoskeletal, cardiac, and various trans-cavity and intraoperative uses, alongside interventional guidance. Key technological enhancements include 'Scribble' for training, 'Power Doppler Imaging+' (PDI+) for visualizing slow blood flows, 'Catheter Vessel Ratio' measurement, 'Probe Check' for automated element diagnostics, 'Shoulder Diagram' for documentation, and the AI-driven 'cNerve' tool for adult nerve detection and tracking during scouting for nerve block procedures. Additionally, the system extends its B-lines tool and Real-Time Ejection Fraction capabilities to pediatric patients (excluding neonates). The cNerve feature was tested on a dataset from 44 individuals, demonstrating performance based on criteria for meaningful and successful nerve sequence detection across various demographics and conditions.

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. What is the specific accuracy and performance (e.g., sensitivity, specificity, positive predictive value) of the cNerve AI tool in differentiating various nerve structures across the documented demographic subgroups and supported nerve block locations?; How does the 'Power Doppler Imaging+' (PDI+) feature quantitatively improve the detection and characterization of slow blood flow compared to standard Power Doppler, especially in challenging anatomical regions or pathological states?; What are the validated benefits of the 'Shoulder Diagram' feature in terms of improving documentation consistency, reducing reporting time, or enhancing follow-up for patients with shoulder disorders?; Are there specific clinical scenarios or patient populations where the expansion of B-lines tool and Real-Time Ejection Fraction to pediatrics (excluding neonates) offers the most significant diagnostic advantages or faces limitations?; What is the typical image acquisition time and processing latency for the cNerve tool during a live nerve block scouting procedure, and how does this impact the real-time usability for clinicians?