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FUJIFILM VisualSonics Announces 510(K) Clearance for Ultra High-Frequency Ultrasound

FUJIFILM VisualSonics Announces 510(K) Clearance for Ultra High-Frequency Ultrasound

Product operates at much higher frequencies than any conventional ultrasound system currently available.

By Business Wire04.25.16
FUJIFILM VisualSonics Inc., a developer of ultra high-frequency ultrasound imaging systems and subsidiary of FUJIFILM SonoSite Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vevo MD, the world’s first ultra high-frequency (UHF) clinical ultrasound system. The Vevo MD is FUJIFILM VisualSonics’ first foray into the clinical market.

Learn more about the Vevo MD in the video below:



“This clearance represents another major accomplishment for FUJIFILM VisualSonics.” said Masayuki Higuchi, president and CEO, FUJIFILM SonoSite. “This 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.”

First commercialized in Europe, the Vevo MD is a unique ultrasound system, as it operates at much higher frequencies than any conventional ultrasound system currently available, according to the company. It allows medical professionals to see what they have never seen before—unparalleled image resolution down to 30 micrometers. The Vevo MD system is compatible with FUJIFILM VisualSonics UHF series of transducers. This patented transducer technology is capable of operating in a range of frequencies up to 70 MHz, a significant increase in resolution compared to conventional ultrasound systems.

“FUJIFILM VisualSonics is proud to be the first to market with this technology,” said Renaud Maloberti, vice president and general manager of FUJIFILM VisualSonics. “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.”

The Vevo MD was designed to play a role in a range of clinical application areas including neonatology, vascular, musculoskeletal, dermatology, and other small parts that are within the first 3 cm of the body.

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

FUJIFILM VisualSonics Inc., develops real time, in-vivo, ultra high frequency ultrasound and photoacoustic imaging systems. With headquarters in Toronto, Canada, FUJIFILM VisualSonics provides imaging technologies for the advancement of preclinical research, particularly in cardiovascular, oncology, neurobiology and developmental biology areas. FUJIFILM VisualSonics is a subsidiary of FUJIFILM SonoSite Inc. and part of FUJIFILM Holdings Corporation.

FUJIFILM SonoSite Inc. develops bedside and point-of-care ultrasound, as well as ultra high-frequency micro-ultrasound technology. Headquartered near Seattle, Wash., the company is represented by 26 subsidiaries and a global distribution network in more than 100 countries.

FUJIFILM Holdings Corporation of Tokyo, Japan, develops products for a broad spectrum of industries, including healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2015, the company had global revenues of $20.8 billion, at an exchange rate of 120 yen to the dollar.
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