Fujifilm earns FDA nod and CE mark for its latest portable ultrasound system

The first-generation SonoSite Edge portable ultrasound system--Courtesy of Fujifilm

Japan's Fujifilm announced 510(k) and CE mark approval of its SonoSite Edge II portable ultrasound system, making it the latest entrant in the fast-growing market. Unlike traditional ultrasound machines, portable ones offer point-of-care diagnosis capabilities.

Features of the latest Fujifilm device include a wide angle display and enhanced transducers that produce higher contrast resolution, according to release. Transducers produce the sound waves that bounce off body tissues and produce echoes, which are then sent to a computer for interpretation, resulting in an image known as a sonogram. And Fujifilm says that its technology protects transducers from being rolled over, stepped on, or twisted.

The new SonoSite replaces the first-generation version, which can provide color images and needle visualization, according to the company website.

"Since SonoSite introduced the first portable ultrasound system in 1999, it has continued to build solutions that anticipate the bedside provider's needs," said Dr. Diku Mandavia, chief medical officer and senior vice president of Fujifilm's SonoSite portable ultrasound unit, in a statement. "The Edge II ultrasound system stays true to the SonoSite legacy of durability, reliability, and ease of use. However, we also incorporated enhancements to accelerate the time to image acquisition, enabling clinicians to make more confident decisions and focus on what matters most, the patient."

In November, Philips went a step further, released the hand-held ultrasound device Lumify, which plugs into a smartphone and connects to an app for image management. It is paid for via $199 monthly subscription.

The move came on the heels of word that private equity behemoth KKR is backing miniaturized ultrasound company Signostics with a $35 million investment. Signostics offers ultrasound systems such as the handheld Signos Bladder Scanner.

- read the release

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