The FDA has granted 510(k) clearance to Escalon Medical Corp.’s tablet-based ultrasound imaging system, the Sonomed Escalon VuPad.
Ardmore, PA-The FDA has granted 510(k) clearance to Escalon Medical Corp.’s tablet-based ultrasound imaging system, the Sonomed Escalon VuPad.
The device-which utilizes touch screen controls-combines Sonomed Escalon’s UBM and newly enhanced B-scan image quality with an ultra-high-resolution screen that has a 25% larger viewing area than other portable devices, according to the company. Proprietary enhanced focus rendering enables the device to capture both still images and high-resolution video clips that can be reviewed frame by frame.
“The new (imaging system) is a revolutionary portable ultrasound device that delivers exceptional image quality in a wide range of ophthalmic applications,” said Richard J. DePiano Jr., chief executive officer of Escalon Medical.
The device will be on display at the annual symposium and congress of the American Society of Cataract and Refractive Surgery in Boston April 25 through April 29.
The company said it is anticipating CE marking and clearance by other international regulatory bodies in the coming months.
“We are pleased by the initial indications and the long-term opportunity surrounding (the device) . . . however, we may experience sales fluctuations as we update our product offering,” added DePiano. “In addition, planned increases to research and development expenses, as well as increased sales and marketing costs could pressure financial results.”
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