Quibim, a global company pioneering imaging biomarkers for precision medicine, announces that its prostate cancer lesion detection capability of its flagship QP-Prostate® CAD solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks a significant milestone in Quibim’s mission to enhance prostate cancer detection and treatment. QP-Prostate, which uses algorithms trained on actual pathology data as ground truth, already holds a CE mark for the European Union, a UKCA mark for the United Kingdom, and approved by the TGA (Australia) meaning it is cleared to be used by clinicians in those markets.

QP-Prostate’s pivotal validation included a standalone assessment and a multi-reader, multi-case study. The study, conducted by Massachusetts General Brigham (MGB) Data Science Office, in collaboration with University Hospitals Ohio, met the superiority endpoint of aided radiological performance versus unaided, as well as the standalone primary endpoint of area under the receiving operating curve (AUROC) using biopsy as ground truth.

With a growing global population at risk of developing prostate cancer, one in eight men being diagnosed with the disease at some point in their lifetime^[1], and MRI scans now being a standard method of diagnosis prior to performing a biopsy, many radiology departments face challenges in managing the surge of prostate MRI required for proper patient care. Quibim’s QP-Prostate CAD addresses this challenge by deploying AI to accelerate image processing, improve radiologists’ accuracy in detecting cancer, and deliver actionable insights to oncology teams. By utilizing advanced imaging techniques, it ensures precise and reliable identification of prostate lesions while delivering risk stratification, aiding in early diagnosis and timely treatment. Additionally, it provides a 3D output of the prostate gland and the lesions.

The system’s clearance as a CADe/CADx in the U.S. follows its successful implementation in the EU, UK, and Australia which leading medical institutions have widely adopted. Hospitals that have implemented the product 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.

As Quibim prepares to enter the U.S. market, the FDA clearance serves as a testament to the company’s dedication to innovation and excellence in medical imaging. The QP-Prostate system is now ready to support U.S. healthcare providers in delivering superior patient care and improving outcomes for those affected by prostate cancer.

Dr. Angel Alberich-Bayarri, CEO and Founder of Quibim, says: “We are excited to receive FDA 510(k) clearance for our QP-Prostate’s lesion detection and diagnosis capability. This validates our technology’s efficacy and strengthens our commitment to improving prostate cancer diagnostics globally.”

“Integrating AI technology into prostate MRI enhances diagnostic precision in identifying clinically significant prostate cancer. It minimizes the need for unnecessary biopsies by improving scan specificity and streamlining workflows by automating tasks like prostate volume and lesion segmentation, ultimately benefiting patients with more efficient and accurate care. There is also a growing market for fusion biopsy and focal therapy, which QP-Prostate is well-positioned to support. We look forward to working with radiologists to help them further improve the early-stage care for patients with suspected or confirmed prostate cancer, which is a group that is sadly growing at a rapid pace in many countries, and we are hopeful that QP-Prostate will make a significant impact in the U.S. healthcare landscape.”

David Bazaga, VP of Product at Quibim, commented: “Enhancing lesion detection in medical imaging has long been a critical focus, and it’s been incredibly rewarding to collaborate with our technical experts and healthcare partners to tailor Quibim’s product to meet their exact requirements. With the recent FDA clearance, we’re excited to bring this solution to the US 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 company designing pioneering tools that unlock imaging data to improve patient outcomes. With offices in New York (United States), Cambridge (UK), Valencia, Madrid, and Barcelona (Spain), the company was born from the ambition of turning imaging into a catalyst for precision health. Quibim leads the forefront of imaging biomarkers research in life sciences, pioneering the development of advanced algorithms that transform imaging data into actionable predictions in oncology, immunology, and neurology. The company leverages the capabilities of MRI, CT, and PET imaging to create regulatory-cleared Medical Devices that are seamlessly integrated into the workflows of healthcare providers worldwide. More than 170 sites are using Quibim products globally.

Quibim has developed several products, including:

• QP-Prostate® is the company’s flagship product for identifying prostate cancer. It was recently updated to include an industry-leading lesion detection capability.
• QP-Brain®, which provides quantification and visualization of imaging findings. This is useful for identifying patterns of brain atrophy and neurodegenerative diseases like Alzheimer’s, multiple sclerosis, and vascular and frontotemporal dementia at earlier stages and makes reporting more effective. US, UK, and EU regulators recently launched and cleared it.
• QP-Insights®, an all-in-one web platform that manages, stores, and quantitatively analyzes medical images and other clinical data, was launched recently and is already used by leading bio-pharmaceutical companies and European research consortiums.
• QP-Liver® improves the diagnosis of diffuse liver diseases by accurately quantifying tissue fat and iron from MRI scans.

Quibim has also announced several high-profile partnerships recently, including Merck KGaA, to develop imaging biomarker models to predict responses of cancer patients to immunotherapy and inform decisions in its global drug development efforts. Additionally, Quibim partnered with Phillips, a leader in the health technology industry, to launch AI-based imaging and reporting solutions for MR prostate exams.

^{[1] https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html}

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