FDA Approves First High-Frequency Ultrasound Machine

Interpreting traditional ultrasound images requires a well-trained eye and extensive training as a technician. In an effort to modernize the technology, Fujifilm has just received US Food and Drug Administration (FDA) clearance for its high-frequency, high resolution ultrasound machine, Vevo MD.

The new technology offers improved resolution over conventional ultrasound machines, so physicians can see detail at a resolution as low as 30 nanometers. While the tool benefits from greater resolution, its penetrative power is only at far as 3 cm inside the body.

The new device will likely be most useful for clinicians in the fields of neonatology, vascular, musculoskeletal and dermatology. Though Fujifilm has a strong background in manufacturing ultrasound devices for preclinical applications, the Vevo MD is the company’s first product for the clinical market.

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

The Vevo MD is already on the market in Europe, where it received a CE mark earlier this year. The device is able to operate at much higher frequencies compared to conventional ultrasound units; the transducer can reach a maximum frequency of 70 MHz.

“As the recognized leader in ultra high frequency imaging systems, FUJIFILM VisualSonics is proud to be the first to market with unparalleled technology,” said Renaud Maloberti, vice president & 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.”

“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,” said Andrew Needles, director of marketing at Fujifilm VisualSonics. “Our hope is that this innovative new technology will lead to new medical discoveries, and ultimately, improved quality of patient care.”