QuantX™ by Qlarity Imaging is the first-ever diagnostic AI software cleared by the U.S. Food and Drug Administration (FDA). It helps radiologists distinguish between cancerous and non-cancerous lesions on breast MRI exams with a greater level of precision and accuracy than traditional computer-aided detection (CAD) software. In the De Novo clinical study required for FDA approval, QuantX increased clinical accuracy by 20 percent and reduced missed breast cancers by 39 percent for all readers in the large and diverse dataset.
Jon T. DeVries, CEO of Qlarity Imaging, explains the company’s mission, “If breast cancer is diagnosed early enough, the five-year survival rate is 99 percent. Tragically, one woman dies every minute from this devastating disease. We are motivated and driven by our mission to bridge this gap.”
With Qlarity Imaging’s patient-centered approach guiding its advancement of QuantX, an upcoming release will feature capabilities to increase accessibility within health systems to provide enhanced value to radiologists, IT professionals, business administrators, and ultimately patients.* QuantX is transitioning from a traditional dedicated workstation to a cloud-based platform to ease the burden on a facility’s IT infrastructure. Accessing QuantX from the cloud will eliminate the need for new servers that would require IT maintenance, offer proactive support for radiologists regardless of their location, and allow for seamless software updates. To bring its innovative technology to more healthcare facilities and patients, Qlarity Imaging will offer its AI as a service through various distribution partnerships.
QuantX will also embody a new app-like format, launching directly from a facility’s existing PACS (picture archive and communication system). The QuantX App will streamline workflows by enabling enterprise-wide availability of images, removing the need to learn a new viewer and adjust custom settings, and exporting findings automatically to the reporting application.
These 10 simple steps—most of which are behind the scenes—illustrate how QuantX will be embedded within the radiologist workflow:
1. MRI sends exam to PACS.
2. PACS routes exam to QuantX server.
3. QuantX server applies motion correction and routes one (or more) new series to PACS.
Being singularly focused on breast imaging while fully embracing forward-thinking technology allows us to truly make a difference in patients’ lives while delivering significant value to all stakeholders
4. QuantX server notifies PACS that exam is ready for analysis.
5. PACS places exam on worklist.
6. Radiologist opens exam in PACS viewer.
7. PACS notifies QuantX with study and user context.
8.QuantX App is launched.
9. Findings routed to report.
10. Archive key images to PACS.
The new version of QuantX addresses many of the current challenges health systems and radiologists face and encourages scalable solutions that strengthen Qlarity Imaging’s vision of transforming breast imaging through expanding its services across all modalities, including new developments in screening and diagnostic procedures. One such advancement the company is focusing on is abbreviated breast MRI (AB-MR) screening.
Studies over the last two decades have shown breast MRI has the highest cancer detection rate of all breast imaging modalities. More recent studies have confirmed the equivalent diagnostic accuracy of AB-MR with full MRI protocols. In addition to being a highly accurate test, the shorter scan and reading times have been the impetus for many practices to already incorporate AB-MR for screening high-risk patients and those with dense breasts.
“Our goal is to take diagnostics to the next level to truly make a difference in patients’ lives. Being singularly focused on breast imaging while fully embracing forward-thinking technology allows us to deliver significant value to all stakeholders,” says DeVries.
*This release is a work in progress. Qlarity Imaging cannot guarantee if or when it will be released or if it will receive the necessary regulatory clearances.
Indication: QuantX is indicated for the assessment and characterization of breast abnormalities from MRI data in patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. QuantX is not intended for primary interpretation of digital mammography images.
Risk Information: QuantX is not intended for primary interpretation of digital mammography images. Labeling also provides information to users about potential limitations of the device related to specific subpopulations. For use by licensed healthcare professionals only.