FDA clears HealthyMyne’s medical imaging analytics

Imaging informatics company HealthMyne said today it won FDA 510(k) clearance for its analytics software package designed for radiologist oncology-related workflow and advanced decision support.

The company said the software provides tracking of nodules or tumors over multiple spatially registered imaging studies to help reveal more information about whether the structure is growing, shrinking or stable.

“By automatically delineating the boundaries of a lung nodule, our software can make other sophisticated measurements within those boundaries – such as quantitatively describing important properties like size, shape, and texture. Physicians can examine these properties to make critical judgements about a patient’s prognosis, follow-up schedule, or how to best treat them,” HealthMyne CTO Roger Chylla said in a press release.

HealthMyne said nodule growth is automatically identified by its software for patients in lung cancer screening programs, which the company said can be an indicator for potential nodule malignancy.

The software package also includes new image characterization and tracking features, as well as time-sequenced Epic electronic health record information, the company said.

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