Imaging Informatics Provider Announces FDA Clearance of New Platform

A new clinical decision support platform for enterprise Picture Archiving and Communication System (PACS) and Vendor Neutral Archives (VNA) has received US Food and Drug Administration (FDA) 510 (k) clearance.

The platform was designed to integrate and align with enterprise PACS and VNA systems using industry-standard formats such as the US American College of Radiology (ACR) Imaging 3.0 initiative.

The platform was developed by HealthMyne (Madison, WI, USA), an imaging informatics company, and is intended to help radiologists provide diagnostic imaging data to clinicians before and after performing an imaging exam during the clinical workflow.

HealthMyne’s image data mining platforms can help radiologist and oncologists increase their workflow efficiency by automating data capture, and structured reports. The platform will provide integrated patient progression timelines, and analytics and enable clinicians to compare data for an individual patient with a patient cohort. HealthMyne’s analytic tools are also intended to help researchers explore quantitative imaging biomarkers, and support improved clinical trials of innovative therapies.

Praveen Sinha, CEO of HealthMyne, said, “Having a strong diagnostic imaging platform cleared by the FDA is the first step in our vision of bringing imaging informatics to mainstream healthcare. Significant achievements are being realized elsewhere through clinical data aggregation and analysis, yet imaging has gone largely untapped. As an example, the potential impact of streamlined patient cohort comparison on personalized medicine is truly exciting.”

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