The U.S. Securities and Exchange Commission has filed fraud charges against a medical imaging firm and its CEO, charging that the CEO made misleading comments about a scanner rejected by the U.S. Food and Drug Administration during a shareholder call.
The SEC said Wednesday that during a November 2010 conference call with shareholders, Dean Janes, founder, chairman and CEO of Burbank, Calif.-based Imaging3 Inc., misled shareholders about the FDA's view of the company's medical device.
According to the complaint, in addition to selling, renting and servicing remanufactured or refurbished mobile imaging devices, the company has made repeated unsuccessful attempts to obtain FDA approval for a medical imaging device known as the Dominion Volumetric Scanner to produce 3D medical diagnostic images in real time.
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