The World's First UHF Clinical Ultrasound System Receives US FDA 510(K) Clearance

A world leader in Ultra High Frequency (UHF) ultrasound imaging systems has announced US Food and Drug Administration (FDA) 510(k) clearance for a first-of-a-kind UHF clinical ultrasound system, after 10 years of successful preclinical research.

The system, which uses much higher frequencies than standard ultrasound systems in use today, and was first commercialized in Europe. The system provides image resolution down to 30 micrometers, and can use UHF transducers that work at frequencies up to 70 MHz.

The FUJIFILM VisualSonics (Toronto, Canada) Vevo MD UHF system is compatible with FUJIFILM VisualSonics UHF series of transducers. UHF technology is intended for imaging small parts in the first 3 cm of the body, in fields such as neonatology, musculoskeletal and vascular imaging, and dermatology, and provides much higher resolution than conventional ultrasound systems. The company expects that the new technology will lead to new medical discoveries, and improved patient care.”

Renaud Maloberti, VP and GM of FUJIFILM VisualSonics, 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.”

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