Fujifilm gets FDA nod for first ultrahigh-frequency ultrasound

Vevo MD--Courtesy of Fujifilm

Ultrasound images are notoriously difficult to discern, often unintelligible to anyone but the most experienced technicians. Fujifilm is looking to fine-tune ultrasound imaging. It's gotten FDA clearance for the first high-frequency ultrasound imaging system, Vevo MD.

The system offers exceptional detail with resolution as fine as 30 micrometers--the equivalent of less than half the size of a grain of sand. However, its usefulness is restricted to structures found within the first 3 cm of the body. It's expected to play a clinical role in specialties including neonatology, vascular, musculoskeletal and dermatology.

Despite that limitation Fujifilm isn't shy about staking out big claims for the new tech. "The Vevo MD is simply the most revolutionary ultrasound technology to come along in decades," boasts the company's site.

"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."

Superficial Hemangioma with Color imaged using the Vevo MD--Courtesy of Fujifilm

Vevo MD is already marketed in Europe, after winning a CE mark in January. It operates at much higher frequencies than conventional ultrasound systems that are available. The transducer is able to operate at a range of frequencies up to 70 MHz, offering a substantial increase in resolution compared to conventional ultrasound.

"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."

Fujifilm reportedly lost out in the recent $6 billion planned acquisition of Toshiba's imaging business to Canon. It's also been weighed down in the years-long regulatory wrangle with duodenoscopes that are insufficiently cleaned and implicated in the transmission of antibiotic resistant bacteria.

- here is the release

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