HealthMyne Announces FDA Clearance of Imaging Analytics Package

MADISON, Wis.--()--HealthMyne, an imaging informatics company, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new analytics software package is designed to provide radiologists with significant workflow efficiencies related to oncology cases, as well as advanced decision support.

New image characterization and tracking features are now provided in a comprehensive, quantitative imaging dashboard, which includes time-sequenced Epic EHR (Electronic Health Record) information. The analytics software also offers convenient tracking of a nodule or tumor over multiple, spatially registered imaging studies. This can reveal crucial information about whether the structure is growing, shrinking, or stable.

Structure change can be particularly useful in monitoring and/or adjusting a patient’s treatment regime. Importantly, with cancer treatment options continuing to increase in both number and specificity, the HealthMyne software can provide valuable quantitative insight for improved clinical decision-making.

Cancer screening programs can also benefit from nodule characterization. As an example, nodule growth is automatically identified by HealthMyne software for patients participating in lung cancer screening programs. This can be an indicator of potential nodule malignancy, and therefore, suggest extra scrutiny.

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

HealthMyne will be exhibiting at the Annual Meeting of the Society of Thoracic Radiology in Scottsdale from March 13 to March 16, 2016.

About HealthMyne:

HealthMyne is an imaging informatics company dedicated to transforming patient care by enabling image data mining within the clinical workflow. Built on an FDA-cleared diagnostic platform, HealthMyne tools will increase radiologist efficiency by automating both data capture and structured reports. HealthMyne software combines imaging and electronic health record data to provide stakeholders with integrated patient progression timelines as well as analytics for comparing individual patients to specific populations. Academic and industrial researchers can use HealthMyne analytic tools to explore quantitative imaging biomarkers, including radiomic signature development, as well as supporting improved clinical trials of innovative therapies.

Contacts

HealthMyne
Del Coufal, del.coufal@healthmyne.com

Release Summary

HealthMyne, an imaging informatics company, announced 510(k) FDA clearance on a new analytics software package. It offers radiologists significant workflow efficiencies and oncology decision support.

Contacts

HealthMyne
Del Coufal, del.coufal@healthmyne.com