iCad Inc. got pre-market approval from the Food & Drug Administration for software it says will locate the best point to perform a needle biopsy of the breast.
The Nashua, N.H.-based computer-aided detection products maker said its PrecisionPoint product won 510(k) pre-market notification clearance from the federal watchdog agency March 31.
PrecisionPoint will be integrated into iCad’s CADvue breast MRI image review software.
According to the company’s FDA application, PrecisionPoint allows the user to select a specific target lesion in the breast and automatically calculates the location and depth of the area of concern. The software locates the best place to perform a biopsy and provides the ability to visualize the appropriate position, according to iCad.