Escalon Medical Corp. (ESMC) announced that the company’s wholly owned subsidiary ‘Sonomed, Inc’ has received 510 clearance from the U.S. Food and Drug Administration. As a result, the company will now be able to fully market their MASTER-VU ophthalmic B-scan ultrasound system without any legal implications. Specifically, the MASTER-VU System consists of a B-scan probe that can be interfaced to a standard personal computer or laptop using Sonomed’s software; converting any personal computer into an ophthalmic ultrasound system.
Barry Durante, Sonomed’s President stated, “The FDA clearance, along with the previously received CE certification, will allow Sonomed to market this new breakthrough instrumentation worldwide. With computers becoming standard in most ophthalmic physician offices, purchasing the probe and software offers complete portability for use in multiple locations. Loading the software in computers in multiple offices allows the physician to carry only the probe from office to office. We expect that the MASTER-VU(TM) will be a valuable addition to our product line in both the U.S. and international marketplace.”
The MASTER-VU system flexible design allows simple installation, low maintenance and immediate user productivity. The MASTER-VU features include:
– Measurement calipers for multiple intraocular measurements.
– Ability to save both 30-second “clips” as well as individual frames on a scrolling frame manager.
– On-screen annotation capability, including text and graphics.
– Easy installation and low maintenance.
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