iCAD nets 510(k) for interventional breast MRI app

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The FDA has granted 510(k) clearance to iCAD for PrecisionPoint, its interventional planning solution for breast MRI that will be offered as an integrated module within the company's CADvue breast MRI image review software.

CADvue is an MRI image review, analysis and BI-RADS compatible reporting solution that generates contrast enhancement curves, dynamic 3D images and quantification of key lesion parameters. CADvue's automation of critical manual steps reduces the time required to generate curves and streamlines radiologists' work flow and diagnosis, according to iCAD.

The company said that the addition of PrecisionPoint, coupled with the new features and product enhancements within CADvue, will give clinicians a set of tools to improve the review and analysis of breast MRI studies, as well as interventional planning.