Venue Go is a portable, general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals to image and analyze the human body and fluid flow. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and more. It offers advanced imaging modes and AI-enhanced tools such as cNerve for nerve tracking, aiding clinicians during procedures like nerve blocks. This device helps clinicians obtain high-quality ultrasound images and analyze them efficiently to improve patient care.
Intended Use
The Venue Go is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include abdominal (GYN and Urology), thoracic/pleural, ophthalmic, fetal/OB, small organ, vascular/peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal, cardiac (adults and pediatric), transrectal, transvaginal, transesophageal, intraoperative (vascular) and interventional guidance.
Technology
Venue Go is a compact, portable ultrasound system that supports multiple transducer types (linear, convex, phased array) and standard acquisition modes including B, M, PW Doppler, CW Doppler, Color Doppler, Power Doppler and Harmonic Imaging. It integrates AI-based tools such as cNerve for nerve detection and tracking during procedures. The system supports wireless communication, DICOM for image storage and utilizes a high resolution color LCD with multi-touch interface.
Performance
The device was evaluated for safety and effectiveness through non-clinical testing following multiple medical electrical equipment standards and ultrasonic diagnostic safety requirements. AI algorithm "cNerve" was tested on a representative dataset of nerve block scouting procedures with 124 sequences and 3776 frames from 44 individuals. The AI showed acceptable nerve detection accuracy across demographic subgroups. No clinical studies were required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/18/2022
3 months - 2
FDA Approval
6/21/2022
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