Eigen granted FDA clearance for prostate cancer imaging tool

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The FDA has granted Eigen clearance for its ei•Nav/Artemis, which offers urologists imaging technology for the detection of prostate cancer.

Using proprietary next-generation 3D/4D imaging, Artemis allows urologists to see inside the prostate in real time during biopsy, guides them with 4D needle navigation during the procedure, maps biopsy locations and generates an image of 3D biopsy coordinates for future reference, according to the Grass Valley, Calif.-based Eigen.

The company said Artemis’ 3D/4D imaging allows doctors to select and biopsy a location within the boundary of the prostate with pinpoint accuracy. The biopsy location is then recorded by Artemis’ patented technology, which allows doctors to revisit or avoid the same area during repeat procedures, Eigen said.

“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,” said Al Barqawi, director of research at the University of Colorado Health Sciences Center in Aurora, Colo. “The benefits of advancements in imaging will improve our ability to accurately guide tissue sampling, improve diagnosis and manage the disease progression.”

Artemis will be introduced at the American Urological Association’s (AUA) meeting May 17 – 22 in Orlando, Fla.