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FujiFilm wins 510(k) for Vevo MD clinical ultrasound system

Fujifilm Sonosite (TSE:4901) subsidiary VisualSonics said today it won FDA 510(k) clearance for its Vevo MD ultra high frequency clinical ultrasound system, the company’s 1st offering in the clinical market.

The Vevo MD is designed for image resolution down to 30 micrometers, and is compatible with FujiFilm VisualSonics UHF series of transducers capable of operating in a range of frequencies up to 70 Mhz.

“This clearance represents another major accomplishment for FujiFilm VisualSonics. This powerful and innovative technology offers unprecedented image resolution capabilities that will have significant impact on the U.S. medical imaging community and the care providers deliver to patients,” FujiFilm SonoSite CEO Masayuki Higuchi said in a press release.

The Vevo MD was designed for use in a range of clinical fields, including neonatology, vascular, musculoskeletal, dermatology and other small parts within the 1st 3 cm of the body, FujiFilm said.

“As the recognized leader in ultra high frequency imaging systems, FujiFilm VisualSonics is proud to be the first to market with unparalleled technology. With the Vevo MD, clinicians can observe the tiniest, most highly detailed anatomy that has never been seen before, which means greatly enhanced potential for diagnoses,” FujiFilm VisualSonics GM Renaud Maloberti said in a prepared release.

“We are confident that Vevo MD is the kind of progressive tool U.S. health care providers will find to be of value for a wide array of applications as well as still unexplored areas. Our hope is that this innovative new technology will lead to new medical discoveries, and ultimately, improved quality of patient care,” VisualSonics marketing director Andrew Needles said in a prepared statement.

In January, FujiFilm said it won CE Mark approval in the European Union for its Vevo MD ultra high frequency clinical ultrasound.

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, UltrasoundTagged With: Fujifilm Holdings