iCAD gets FDA nod for colon cancer detection product
Nashua, N.H.-based image and analysis solutions company iCAD Inc. has announced that the U.S. Food and Drug Administration has approved the company’s VeraLook computer-aided detection product used to analyze virtual colonoscopy exams.
The image analysis product finds polyps in the 1,200 to 1,500 three-dimensional images a patient may have from a virtual colonoscopy exam. Also called CT colonography, the virtual colonoscopy is a minimally invasive procedure. VeraLook launched in Europe in 2009.
ICAD (Nasdaq: ICAD) develops systems to aid in early detection of multiple cancers, including breast and prostate cancer, and in the future, lung cancer. It offers upgradeable systems and workflow solutions for mammography technologies, including those that are film-based, or use digital radiography and computed radiography. The systems also work with MRI and computed tomography machines.
In April 2009, iCAD’s PrecisionPoint interventional planning breast magnetic resonance imaging (MRI)-guided software received 510k clearance from the U.S. Food and Drug Administration.