Rugged, Portable Ultrasound System Receives Regulatory Approval

The system received was approved for use in the US and in Europe after receiving US Food and Drug Administration (FDA; Silver Spring, MD USA) 510(k) clearance, and the CE marking. FujiFilm SonoSite is the world leader in bedside and point-of-care ultrasound, and an industry leader in ultra-high frequency micro-ultrasound technology.

Diku Mandavia, MD, FACEP, FRCPC, chief medical officer, senior vice president, FUJIFILM SonoSite and FUJIFILM Medical Systems USA, said, “Since SonoSite introduced the first portable ultrasound system in 1999, it has continued to build solutions that anticipate the bedside provider’s needs. The Edge II ultrasound system stays true to the SonoSite legacy of durability, reliability, and ease of use. However, we also incorporated enhancements to accelerate the time to image acquisition, enabling clinicians to make more confident decisions and focus on what matters most, the patient.”

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