An artificial intelligence (AI) assisted teleradiology platform, from Rology has secured US Food and Drug Administration (FDA) 510(k) clearance as a Class II Medical image management and processing system.
The image management and processing system can acquire Digital Imaging and Communications in Medicine (DICOM) images from multiple imaging modalities and systems which are then encrypted, anonymised, stored, and distributed to radiologists based on their availability and specialty.
Rology claims the on-demand and 2-sided teleradiology platform is the first of its kind to receive FDA 510(k) Class II clearance.
Mahmoud Eldefrawy, Chief Medical Officer of Rology said: “The FDA clearance not only emphasizes our commitment to cybersecurity and regulatory adherence but also paves the way for promising collaborations with major radiology and hospital chains.”
Moaaz Hossam, Chief Business Officer of Rology said: “This clearance doesn’t just represent technological advancement; it symbolizes hope for countless medical providers, especially SMEs (standalone imaging centers) and the underserved public hospitals.”
The platform includes functions like Automatic Image Acquisition Tool also known as Rology Connect, an Automatic Workflow Management System, DICOM Viewer, Reporting Tools, and Peer Review Tools that are all FDA 510(k) cleared.
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J. David Giese, CEO of Innolitics said: “Our collaboration with Rology exemplifies the power of synergy. Together, we’ve taken significant strides in the realm of radiology, with the aim of delivering unparalleled healthcare services globally. Rology’s dedication, combined with our regulatory and engineering consulting expertise, made the FDA clearance not just a possibility, but a reality. This achievement is a testament to the fact that when vision meets expertise, boundaries are expanded, and genuine, impactful change is realized.”
Currently Rology is working with over 150 clients in nine countries and focuses on delivering its tech to rural and low-income demographics.