Fujifilm VisualSonics, a provider of ultra-high-frequency ultrasound imaging systems and subsidiary of Fujifilm SonoSite, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vevo MD, an ultra-high-frequency (UHF) clinical ultrasound system.
Following multiple successes in preclinical research over the last ten years, the Vevo MD is Fujifilm VisualSonics’ first foray into the clinical market.
Fujifilm SonoSite president and CEO Masayuki Higuchi said: "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 US medical imaging community and the care providers deliver to patients."
Commercialised first in Europe, the Vevo MD is claimed to be a unique ultrasound system as it operates at much higher frequencies than any conventional ultrasound system currently available.
As well as providing an 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, which is a significant increase in resolution than traditional ultrasound systems.
The Vevo MD is intended for 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.
Fujifilm VisualSonics vice president and general manager Renaud Maloberti said: "As the recognised leader in ultra-high-frequency imaging systems, FujifilmVisualSonics 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 director of marketing Andrew Needles said: "We are confident that Vevo MD is the kind of progressive tool US 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."
Image: Fujifilm VisualSonics’ Vevo MD. Photo: courtesy of FUJIFILM VisualSonics, Inc.