iCAD Submits Lung Cancer Detection Support Product to the FDA

iCAD, a provider of computer-aided detection (CAD) solutions for the early identification of cancer, recently submitted its premarket notification 510(k) application with the FDA seeking clearance to market and sell its first product for use in the detection of lung cancer.

As an image-processing application intended to support computed tomography (CT) review workstation software, iCAD's lung cancer detection product has been designed to make the medical review of lungs in CT scans more efficient and productive. The solution identifies roughly spherical objects in the lung that meet radiologist-specified size, shape and brightness criteria, enabling healthcare professionals to improve workflow by spending more time reviewing potential areas of lung cancer concern.

Distribution agreements for iCAD's lung cancer detection products are already in place with TeraRecon and Viatronix, both of which are expected to commence marketing of the offering as soon as FDA approval is received and product development and release plans are finalized.