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Escalon Medical obtains FDA 510(k) approval for Sonomed Escalon VuPad system

Escalon Medical, a US-based medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Sonomed Escalon VuPad tablet-based ultrasound imaging system.

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The VuPad has portable ergonomic design and offers A-scan, B-scan, and/or UBM modalities. The device combines Sonomed Escalon’s UBM and newly enhanced B-scan image quality with an ultra-high-resolution screen that has 25% larger viewing area than other portable ultrasound devices.

Escalon Medical’s new tablet-based ultrasound imaging system features Enhanced Focus Rendering which enables capture of both crisp still images and high-resolution video clips that can be reviewed frame-by-frame.

The device features intuitively designed touch screen controls, elegant user interface, wireless interconnectivity to EMR’s, image management systems, and printers, multi-touch ultra-high-resolution touch screen with pinch zoom functionality, and outstanding image quality and measurement accuracy.

Escalon Medical expects CE Mark approval and other approvals from international regulatory bodies for the device in the coming months. The company expects immediate shipments of VuPad systems as orders are received and manufacturing ramps up to meet demand.

Escalon Medical CEO Richard J. DePiano Jr. noted that the new VuPad is a revolutionary portable ultrasound device that delivers exceptional image quality in a wide range of ophthalmic applications.

"It also demonstrates the company’s ongoing commitment to developing and delivering new best-in-class solutions to build on our position as a leader in ophthalmic ultrasound for over 30 years.

"We are pleased by the initial indications and the long term opportunity surrounding the VuPad and other new products in our pipeline; however, we may experience sales fluctuations as we update our product offering. In addition, planned increases to research and development expenses as well as increased sales and marketing costs could pressure financial results," DePiano added.

The VuPad will be on display at The Exchange 2014, Vision Source’s North American Meeting in Boston, 9 April to 12 April and at the Annual Symposium and Congress of the American Society of Cataract and Refractive Surgery (ASCRS) in Boston, 25 April to 29 April 2014.


Image: Escalon Medical’s Sonomed Escalon VuPad system gets FDA approval. Photo: Courtesy of PRNewswire/Escalon Medical Corp.