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.

The SEC said in its complaint, which was filed Tuesday in the U.S. District Court in Los Angeles, that a key component of the company's business plan and its ability to generate a profit depends upon its ability to market and sell the Dominion Scanner.

The SEC said in its statements that Mr. Janes' conference call was held after the FDA denied clearance for the third time for Imagine3 to market its scanner.

The SEC said Mr. Janes did not discuss issues raised by the FDA in an October 2010 letter, such as the device's potential for overheating, and the fact that some sample images the company submitted were “scientifically invalid and useless.”

"SEC charges medical imaging firm CEO for lying on conference call" originally appeared in Business Insurance.