Fujifilm SonoSite obtains FDA 510(k) clearance for X-Porte ultrasound kiosk

10 November 2013 (Last Updated November 10th, 2013 18:30)

US-based developer of ultrasound tools Fujifilm SonoSite has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Porte ultrasound kiosk.

X-Porte

US-based developer of ultrasound tools Fujifilm SonoSite has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Porte ultrasound kiosk.

The new-generation point-of-care ultrasound kiosk incorporates SonoSite's proprietary Extreme Definition Imaging (XDI) technology, which reduces visual clutter from side-lobe artifacts that affect all ultrasound imaging regardless of system size.

Fujifilm SonoSite chief technology officer JJ Hwang has created the XDI technology following 35 years of applied ultrasound research.

According to the company, X-Porte delivers usability and interoperability through its visual learning guides for maximising XDI technology.

X-Porte ultrasound kiosk features advanced signal processing for high-resolution imaging, 3D animated clinical guides, and a multi-touch gesture-driven user interface.

Users can personalise the touchscreen interface and can easily control the system without using keys or buttons.

The kiosk serves a broad spectrum of users, from novice to advanced, and represents a new design for ultrasound.

SonoSite president and CEO Kevin M Goodwin said: "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.

"Then, we blended in our own inspiration from key engineers at our company, creating a remarkable new tool built from the ground up.

"The design genesis is aimed at enabling any and all members of a healthcare team, nurses, mid-level providers, and even a physician-hospital administrator, to be empowered to take advantage of X-Porte's high-performance visualisation."

"The kiosk represents a new design for ultrasound technology."

X-Porte was developed by SonoSite's user-experience design team for optimising workflow and use in various environments.

The user interface, which is easily cleanable and sealed, has minimal crevices for optimal infection control.

In addition, the glass surface allows cleaning with a wide range of disinfectants without deteriorating the surface over time.

While the X-Porte ultrasound core can be easily detached from the kiosk and simply upgraded though straightforward software updates, the kiosk can be moved with ease in the corridors and alongside patient beds as it has a detachable use option for low-footprint environments.

The X-Porte ultrasound kiosk, which is already available in parts of Europe and Asia-Pacific, will be available in the US effective immediately.

The device will be available in a stationary or a detachable use model and comes with a five-year warranty.


Image: Fujifilm SonoSite receives FDA 510(k) clearance for X-Porte ultrasound kiosk. Photo: courtesy of Fujifilm SonoSite, Inc.