OMB Individually Reported

Venue Fit

High riskExact public inventory row

Description

Venue Fit is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body, by ultrasound imaging and fluid flow analysis. The Venue Fit is a compact, portable system with a small footprint. The system can be hand-carried using the integrated handle, placed on a horizontal surface (if kickstand is attached), attached to a mobile cart, or mounted on the wall. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long-term use or through an internal battery for a short time with full functionality and scanning. The Venue Fit utilizes a variety of linear, convex, and phased array transducers that provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system is capable of displaying the patient's Electrocardiogram (ECG) trace, synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal, used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

Detailed example

The cNerve algorithm may help the user detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material.

AI / analytics pattern

Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Supports ultrasound procedures.

Controls / human review

ATO: Not reported; PIA: Not published