FDA grants 510(k) clearance to new HealthMyne platform
HealthMyne, an imaging informatics company, announced this week that the Food and Drug Administration (FDA) has granted 510(k) clearance to its new platform.
This clearance means the platform has been approved to be marketed in the United States.
According to HealthMyne, this new platform will “streamline clinical decision support and integrate with enterprise PACS and vendor-neutral archives using industry-standard formats.” It also aligns with the American College of Radiology Imaging 3.0 initiative.
“Having a strong diagnostic imaging platform cleared by the FDA is the first step in our vision of bringing imaging informatics to mainstream healthcare,” Praveen Sinha, CEO of HealthMyne, said in a statement. “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.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.