FDA gives clearance for FUJIFILM VisualSonics ultra-high frequency ultrasound system

FUJIFILM VisualSonics Inc., a subsidiary of FUJIFILM SonoSite, has announced that its Vevo MD ultra-high frequency clinical ultrasound system has received 510(k) clearance from the FDA.

The clearance is the first of its kind for an ultra-high frequency ultrasound system designed for use on humans, the company said in a press release.

“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,” said Masayuki Higuchi, FUJIFILM SonoSite president and CEO.

Already commercially available in the European market, Vevo MD operates at elevated frequencies and is capable of producing image resolution down to 30 micrometers for a variety of procedures, including vascular, musculoskeletal, and neonatal imaging.

“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,” added Renaud Maloberti, vice president and general manager of FUJIFILM VisualSonics.

Read the official announcement.