FDA Clears Quibim’s QP-Prostate® CAD for Lesion Detection and Diagnosis
Quibim, a global leader in imaging biomarkers for precision medicine, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its QP-Prostate® CAD system. This cutting-edge technology, designed for prostate cancer lesion detection, is now approved for use by healthcare professionals in the U.S. The approval underscores Quibim’s commitment to improving prostate cancer detection and treatment using artificial intelligence (AI)-driven imaging solutions.
The QP-Prostate® CAD system employs advanced algorithms trained on actual pathology data, ensuring a high level of accuracy in detecting prostate lesions. The solution had already received regulatory clearances in multiple international markets, including the European Union (CE mark), the United Kingdom (UKCA mark), and Australia (TGA approval). With the FDA clearance, Quibim is now poised to make a significant impact in the U.S. healthcare market, providing radiologists and oncologists with a powerful tool for enhancing early detection and diagnosis of prostate cancer.
Validating QP-Prostate’s Efficacy Through Rigorous Studies
The validation process for QP-Prostate® included an extensive standalone assessment and a multi-reader, multi-case study. Conducted by Massachusetts General Brigham (MGB) Data Science Office in collaboration with University Hospitals Ohio, the study demonstrated the superior performance of AI-assisted radiological assessments compared to traditional methods. The system met key validation criteria, including the primary endpoint of area under the receiver operating characteristic (AUROC) curve, using biopsy results as the ground truth.
Addressing the Growing Burden of Prostate Cancer
Prostate cancer is a major global health concern, with one in eight men diagnosed at some point in their lifetime. The increasing reliance on MRI scans as a standard diagnostic tool before biopsy has placed significant pressure on radiology departments. Quibim’s QP-Prostate® CAD system addresses these challenges by leveraging AI to enhance image processing speed, improve detection accuracy, and deliver actionable insights to oncology teams. The system not only identifies prostate lesions but also offers risk stratification, facilitating timely diagnosis and intervention. Additionally, it generates a 3D visualization of the prostate gland and lesions, further aiding clinical decision-making.
Widespread Adoption and Clinical Integration
The QP-Prostate® CAD system has already gained traction in key global markets, with leading medical institutions incorporating it into their clinical workflows. Hospitals that have successfully implemented the solution include Hospices Civils de Lyon – CHU de Lyon, Hospital Universitario Ramón y Cajal, Hospital Universitario Nuestra Sra. del Rosario, and Hospital Universitario de La Ribera. The system’s widespread adoption reflects its effectiveness in enhancing prostate cancer diagnostics and streamlining radiology workflows.
Quibim’s Expansion into the U.S. Market
With the FDA clearance, Quibim is set to expand its footprint in the U.S., bringing its AI-powered imaging solutions to healthcare providers across the country. Dr. Angel Alberich-Bayarri, CEO and Founder of Quibim, emphasized the importance of this milestone, stating, “We are excited to receive FDA 510(k) clearance for QP-Prostate’s lesion detection and diagnosis capability. This validates our technology’s efficacy and strengthens our commitment to improving prostate cancer diagnostics globally.”
Quibim’s AI integration into prostate MRI enhances diagnostic precision, reducing the need for unnecessary biopsies by improving specificity. It also streamlines workflows by automating essential tasks, such as prostate volume measurement and lesion segmentation. With an increasing market for fusion biopsy and focal therapy, QP-Prostate® is well-positioned to support these advancements in prostate cancer care.
David Bazaga, VP of Product at Quibim, added, “Enhancing lesion detection in medical imaging has long been a critical focus. With the recent FDA clearance, we’re excited to bring this solution to the U.S. market. The use of pathology data to train and validate our algorithm has been pivotal, and we’re eager to see the real-world impact it will have in the future.”
About Quibim
Quibim is a pioneering company dedicated to unlocking imaging data to improve patient outcomes. With offices in New York, Cambridge, Valencia, Madrid, and Barcelona, the company has established itself as a leader in imaging biomarkers research for life sciences. Quibim specializes in developing advanced algorithms that transform medical imaging data into actionable predictions across oncology, immunology, and neurology. By leveraging MRI, CT, and PET imaging, Quibim creates regulatory-cleared medical devices seamlessly integrated into clinical workflows worldwide.
Quibim’s Expanding Portfolio of AI-Driven Solutions
Beyond QP-Prostate®, Quibim has developed a range of innovative imaging solutions, including:
- QP-Brain®: Provides quantification and visualization of imaging findings, aiding in early detection of neurodegenerative diseases such as Alzheimer’s, multiple sclerosis, and various forms of dementia.
- QP-Insights®: A comprehensive web platform that manages, stores, and analyzes medical images and clinical data, currently utilized by leading biopharmaceutical companies and European research consortiums.
- QP-Liver®: Enhances the diagnosis of liver diseases by accurately quantifying tissue fat and iron from MRI scans.
Strategic Partnerships Driving Innovation
Quibim has established strategic collaborations with leading healthcare and pharmaceutical companies to advance imaging biomarker research. Notably, the company has partnered with Merck KGaA to develop imaging models that predict cancer patient responses to immunotherapy. Additionally, Quibim has teamed up with Philips, a global health technology leader, to introduce AI-based imaging and reporting solutions for prostate MRI exams.
Transforming Prostate Cancer Diagnostics with AI
The FDA clearance of QP-Prostate® CAD marks a significant step forward in prostate cancer care. By integrating AI-powered imaging solutions into clinical practice, Quibim is enabling healthcare providers to detect and diagnose prostate cancer with unprecedented accuracy and efficiency. As the company expands into the U.S. market, its technology is set to make a lasting impact on prostate cancer diagnostics and patient outcomes worldwide.
