eZono obtains FDA 510(k) approval for eZono 4000 tablet ultrasound system with eZGuide

18 March 2014 (Last Updated March 18th, 2014 01:00)

Tablet ultrasound systems developer eZono has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its eZono 4000 dedicated procedural guidance system with eZGuide technology.

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Tablet ultrasound systems developer eZono has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its eZono 4000 dedicated procedural guidance system with eZGuide technology.

The eZono 4000 dedicated procedural guidance system features eZGuide, a freehand navigation technology that enables point of care clinicians to perform procedures with greater accuracy, increased confidence and the ability to clearly identify the position of the needle tip, without requiring special needles or additional equipment.

According to eZono, the eZGuide requires no expensive hardware, special needles or any needle gauges.

The eZono4000 has a new 12.1in LED touchscreen that provides brightness required to fully appreciate the image in the operating room or critical care areas. It runs on the proprietary Linux operating system.

It uses eZono's new generation transducer technology, with increased processing offering advanced imaging capabilities with automated optimisation. The eZono 4000 offers up to four hours of video storage or 250,000 still images.

"As healthcare costs rise, it becomes imperative for companies to provide quality solutions at affordable prices."

eZono CEO Graham Cox said: "eZono is passionate about bringing practical and affordable solutions to clinicians in their everyday practice and we are delighted to bring this technology to the United States for needle guidance applications.

"As healthcare costs rise, it becomes imperative for companies to provide quality solutions at affordable prices. eZono addresses the needs of improving patient safety with increased efficiency by making essential equipment more easily accessible with minimal ongoing costs per procedure."

In November 2013, eZono obtained CE Mark approval in Europe for the eZono 4000 tablet ultrasound system with eZGuide technology. Currently, the eZono 4000 is available for sale in Europe and all countries accepting CE Mark.

According to GlobalData estimates, the US ultrasound systems market was valued at $1.45bn in 2012 and is expected to grow at a CAGR of 5.2% to reach $2.07bn by 2019.


Image: eZono 4000 ultrasound system with needle guidance. Photo: courtesy of BusinessWire/eZono AG.