FDA Clears Ultrasound Kiosk from SonoSite

The U.S. Food and Drug Administration (FDA) has approved a point-of-care ultrasound system from Fujifilm SonoSite Inc. that has already hit the market in parts of Europe and Asia.

The company’s X-Porte Ultrasound Kiosk — available in a stationary or detachable use model — was designed to serve a broad spectrum of clinicians (from novice to experienced professionals), and represents a new use paradigm for ultrasound, according to executives.

“This is a major accomplishment for SonoSite,” President/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 consumer technologies. Then, we blended in our own inspiration from key engineers at our company, creating a new tool built from the ground up.”

The defining advancement behind the X-Porte is a new imaging technology never before used in ultrasound systems: SonoSite’s proprietary Extreme Definition Imaging (XDI) technology, developed from 35 years of applied ultrasound research by Chief Technology Officer J.J. Hwang. XDI significantly reduces visual clutter from side-lobe artifacts that affect all ultrasound imaging regardless of system size. “I believe this reduction in visual clutter sets a new bar in point-of-care image quality,” said Hwang, who described the XDI technology as “an entirely new way to create an ultrasound image. It allows the user to realize much higher resolution.”

To maximize the utility of the XDI technology, X-Porte delivers optimum usability and interoperability through its visual learning guides. The kiosk integrates high-resolution ultrasound imaging synchronously with 3-D animations that enable “any user, any time of day” to make the most of the operating the technology. These learning modules can be used simultaneously with live scanning to optimize in-the-moment performance and user consistency.

“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 visualization,” Goodwin said.

SonoSite partnered with product designers and experts in advanced automotive animation modeling and distance medical learning to create the kiosk. In addition, a consortium of expert physician educators contributed their expertise for each 3-D application module.

The team was led by Henry Ford Hospital Chair of Surgery Scott Dulchavsky, M.D., Ph.D, who has pioneered medical training tutorials for astronauts. “We were excited to partner with Sonosite in taking this evolutionary step in real-time learning,” Dulchavsky said. “X-Porte represents the convergence of our expertise in advanced animated tutorials with the latest in consumer-like ultrasound design. This is a great step forward onto the frontier of visualization through point-of-care ultrasound education.”

SonoSite’s User-Experience Design Team developed X-Porte for optimized workflow and use in varied environments. The multi-touch, gesture-driven user interface, comparable to those found in the consumer world, can be personalized by the user and controlled with the glide of a hand and without keys or buttons.

The sealed user interface has minimal crevices to facilitate optimal infection control. The glass surface has been tested against incidental spills and allows cleaning with a wide range of disinfectants without deteriorating the surface over time. The kiosk’s slender profile lends itself to easy navigation down corridors and alongside patient beds; it has a detachable use option for low-footprint environments, executives noted. The X-Porte ultrasound core can easily be detached from the kiosk as well as upgraded though software updates or an engine exchange.

Based in Bothell, Wash., SonoSite develops hand-carried and mountable ultrasound systems.