Imaging3 outlines FDA resubmission strategy for its 3D real-time imaging device

CEO Dean Janes commented that the company has finalized its general resubmission strategy after a thorough review with the company’s FDA legal and technical consulting team. Implementation of the strategy involves the following three phased approach: First, the development of protocols for collecting comparison imaging data. Second, with the assistance of the consultant team, meet with the FDA to present the protocols with the goal of reaching consensus with the Agency to help ensure a viable resubmission. The third and final phase is the acquisition of images based on the approved imaging protocols and combining those images and data with the overall package and final submission to the FDA.
Imaging3, founded in 1993, is a leading provider of advanced technology medical imaging devices. The company has developed a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time. Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.