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FDA clears first-ever ultra high frequency clinical ultrasound

por Lauren Dubinsky, Senior Reporter | April 26, 2016
Medical Devices Pediatrics Ultrasound X-Ray
The Vevo MD
Fujifilm VisualSonics Inc. announced on Friday that it received FDA clearance for its Vevo MD ultra high frequency (UHF) clinical ultrasound system, making it the world’s first UHF ultrasound approved for use on humans.

"Receiving FDA 510(k) clearance was a pivotal moment for Fujifilm VisualSonics and the medical imaging community at large," Andrew Needles, director of marketing and product management, told HCB News. "For years there had been a limit to the resolution that ultrasound could provide, but now that barrier has been broken."

The Vevo MD operates at much higher frequencies than the conventional ultrasound systems on the market. Clinicians are able to view images with resolution down to 30 micrometers, which is something that wasn’t offered previously.

It’s compatible with a family of transducers that are able to operate in a range of frequencies up to 70 MHz, which is a huge increase in resolution compared to what other ultrasound systems are capable of.

The Vevo MD is geared for neonatology, vascular, musculoskeletal, dermatology applications and other areas that are within the first 3 centimeters of the body. It can do everything from imaging infants in the neonatal ward to monitoring subtle changes in blood flow in the major arteries of the body.

Neonates and pediatrics require small transducers with great resolution. In the neonatal intensive care unit, a physician might attempt to perform a line insertion into a critically-ill premature newborn, which involves finding a blood vessel in a very tiny wrist.

The Vevo MD was designed specifically with vascular applications in mind. A couple of the applications it can be used for are assessing peripheral vessels in diabetes and other circulatory conditions and visualizing flow patterns in atherosclerotic or abnormal vessels.

Musculoskeletal imaging involves evaluating the hands, wrists, feet, knees, arms and shoulder regions. It can help clinicians detect and monitor inflammatory arthritis, differentiate normal and inflamed tendons, diagnose carpal and tarsal tunnel syndrome and assess pediatric hip dysplasia.

For dermatology, Vevo MD can be used to image melanoma, lipomas, hair loss, foreign body identification and lumps and bumps. It can also be used to image small anatomy, like nerves, hand transplants, thyroids and glands, lymph nodes and male reproductive organs.

"Ultra high frequency technology will truly allow medical professionals to see what they have never seen before, by providing unmatched image resolution," said Needles. "The goal is that this will lead to better diagnoses, new medical discoveries, and an overall advancement in the quality of patient care."

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