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Prostate cancer affects more men in the U.S. than any other cancer, with nearly 30,000 of those diagnosed dying of the disease each year.

A new imaging device developed by ei*Nav/Artemis and recently cleared by the U.S. Food and Drug Administration just might better those odds.



Eigen, a Grass Valley, CA company known for developing innovative, affordable medical imaging solutions, describes Artemis as using proprietary, next-generation 3D/4D imaging to enhance urologists' existing imaging machines, the vast majority of which are now 2D. Artemis allows doctors to virtually see inside the prostate in real time during a biopsy, guiding them with 4D needle navigation during the delicate procedure. This ability allows doctors to select and biopsy locations with the boundary of the prostate with pinpoint accuracy then maps biopsy locations and generates an image of 3D biopsy coordinates for future reference.

The location is then recorded by Artemis' patented registration technology which allows urologists to revisit or avoid the exact same area during repeat procedures.

"With an estimated 1.5 million biopsies performed each year, conventional biopsy is blind to cancer, as 20 to 30 percent of cancers are missed, and detected cancer may not be clinically relevant," explains Al Barqawi, director of research at the University of Colorado Health Sciences Center where, within weeks, the first Artemis imaging systems will be in use, along with UC San Francisco before being immediately available throughout the U.S.

"The benefits of advancements in imaging will improve our ability to accurately guide tissue sampling, improve diagnosis and manage the disease progression. We will be able to treat patients to what they have, not what we think they have," Dr. Barqawi adds.

According to sources at the FDA, the ei*Nav/Artemis Prostate Ultrasound Machine's "clearance" means it has been approved for marketing in the United States. FDA clearance and/or approval, two similar paths toward the goal of consumer sales, assures that the product has met FDA guidelines for the United States.

Notes Peper Long, FDA Public Affairs officer, "The FDA can't clear products for worldwide use." However, news that prostate gland biopsies now have additional help on the way to better pinpoint and treat tumors is welcome news stateside.

Indeed, according to Jennifer George, Eigen spokesperson, the new ei*Nav/Artemis imaging device was introduced at the American Urological Association's (AUA) annual meeting in Orlando, FL May 17-22 with "incredible response from the medical community. Doctors can't wait to get their hands on this machine," George notes.

Price for the imaging machine will range between $85,000 to $125,000. The graduated fee will depend on the number of doctors using it.

"The machine is priced the same for clinics or individual doctors," George says, "but clearly the more doctors who are able to use it, the more affordable it becomes."