Submitted by kBLASTER Team on
by Business Wire
MADISON, Wis.--(BUSINESS WIRE)--HealthMyne, an imaging informatics company, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new imaging informatics platform is designed to streamline clinical decision support and integrate with enterprise PACS and vendor-neutral archives using industry-standard formats.
HealthMyne’s team has leveraged their previous clinical and commercial success within image management to create this innovative software foundation. The new system directly aligns with the ACR (American College of Radiology) Imaging 3.0 initiative which addresses the radiologist’s emerging role as diagnostic imaging consultant to all clinicians, both before and after the imaging encounter.
“Having a strong diagnostic imaging platform cleared by the FDA is the first step in our vision of bringing imaging informatics to mainstream healthcare,” said Praveen Sinha, CEO of HealthMyne. “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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