US-based Fujifilm SonoSite has received 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Porte ultrasound kiosk, a new generation of point-of-care ultrasound.
This integrates advanced signal processing for high-resolution imaging, 3D animated clinical guides, and a multi-gesture user interface.
The kiosk was created to serve a broad spectrum of users, from novice to advanced, and represents an entirely new design and use paradigm for ultrasound.
The device is developed using its proprietary Extreme Definition Imaging (XDI) technology that reduces visual clutter from side-lobe artifacts.
SonoSite president and CEO Kevin M Goodwin said this is a major accomplishment for SonoSite and a defining moment in the next phase of its innovation strategy.
"Working side-by-side with hundreds of clinicians from the frontlines of medicine worldwide, we combined their many insights with the most innovative consumer technologies available today," Goodwin added.
"Then, we blended in our own inspiration from key engineers at our company, creating a remarkable new tool built from the ground up."
The device is available in a stationary or a detachable use model and is already available in parts of Europe and Asia-Pacific.
The company will begin shipping the X-Porte kiosk in the US effective immediately.