VTI gearing up for Instatrak launch; image-guided surgery system clears FDA in 75 days.
This article was originally published in The Gray Sheet
Executive Summary
VTI SCALING UP PRODUCTION OF INSTATRAK IMAGE-GUIDED SURGERY SYSTEM for sinusitis following clearance of the device on April 8. Visualization Technology, Inc. is waiting until installation of manufacturing molds for disposable components of the system is complete before its official launch, which is expected to occur in three to four months. Clearance of the Instatrak 510(k), which was submitted in January, came sooner than expected, and VTI currently is marketing systems equipped with reusable instruments to hospitals that were involved in the company's clinical trials.
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