Carestream Gains Clearance for Lesion Management Module

Rochester, N.Y.-based Carestream Health has gained U.S. Food and Drug Administration 510(k) clearance for its new lesion management module, a native oncology follow-up application that can be added for the company’s Vue PACS (picture archiving and communication system).

Carestream’s new lesion management tools are designed to enhance assessment of cancer patients by providing semi-automatic tracking and segmentation of lesions from modalities and other vendors’ PACS systems. Each measurement generates an anatomical bookmark within the exam, which radiologists reportedly then can navigate and diagnose. The company claims the tools should also increase diagnostic confidence and radiologist productivity. According to Carestream, making these tools available as an optional native PACS module helps eliminate the cost of dedicated workstations.

“The proven volumetric registration combined with the new lesion management feature in our Vue PACS synchronizes views from current and prior exams, which makes it much faster and easier for radiologists to measure and compare lesions, as well as tumors, nodules, and other anatomical structures,” said Cristine Kao, Carestream’s global marketing manager for healthcare information solutions. “The comparison results are displayed with each exam and can be embedded into the final diagnostic report for other clinicians for review.”

According to Carestream, the lesion management application also can equip radiologists with the ability to generate comprehensive oncology imaging reports in accordance with industry standards such as Response Evaluation Criteria in Solid Tumors (RECIST). Consistent, standardized oncology image reporting allows for clearer and more meaningful communication and collaboration between radiologists, oncologists, and referring physicians.

Carestream Health provides dental and medical imaging systems and healthcare information technology solutions; X-ray film and digital X-ray systems for non-destructive testing; and advanced materials for the precision films and electronics markets.

Photo of Carestream’s Vue PACS courtesy of Carestream Health.