Leading Ultrasound Imaging Vendor Announces FDA 501(k) Clearance for New Visualization Solution

A company specializing in designing innovative ultrasound tools, and point-of-care visualization, announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its newest medical visualization solution, intended to meet the needs of mobile clinicians.

Clinicians often rely on mobile ultrasound systems for point-of-care diagnosis of patients. The new solution enables clinicians to store exam findings, submit reports, and access learning resources and patient information. The system also connects with remote providers to provide near real-time assessment. This makes the system suitable for use in the field and in telemedicine.

The iViz solution was developed by FUJIFILM SonoSite (Bothell, WA, USA), a world leader in bedside and point-of-care ultrasound solutions, and ultra-high frequency micro-ultrasound technology. The iViz is a next generation architecture and platform that integrates ultrasound systems with supporting medical IT systems. The iViz is the first medical visualization solution that has bidirectional Electronic Medical Record (EMR) connectivity through the FUJIFILM Synapse Vendor Neutral Archive (VNA). The iViz automatically takes patient demographics from the EMR saving clinicians’ time and effort, and can send patient reports to the EMR. The iViz is based on the Android Operating System (OS) and includes web-browsing, email and ECG capabilities. The system is light-weight, and features a high-resolution, seven-inch display touchscreen, a wide dynamic range, and color flow images, and multiple imaging modes and exams to meet the needs of different medical providers.

Masayuki Higuchi, president and CEO, FUJIFILM SonoSite, said, “iViz is a revolutionary solution for clinicians and represents a landmark in FUJIFILM SonoSite’s innovation. It achieves new levels of image performance and provides unprecedented connectivity in a highly mobile platform. Through iViz, we expand our core mission of increasing access to ultrasound to improve patient care quality and reduce healthcare costs."

Related Links:
FUJIFILM SonoSite
iViz Video