Quibim Receives FDA 510(k) Clearance for qp-Prostate New AI Solution for Prostate MRI Analysis

VALENCIA, Spain, March 4, 2021 /PRNewswire/ -- Quibim, a global leader in whole-body medical imaging analysis, announced today the launch of qp-Prostate, its latest and most advanced prostate AI based Magnetic Resonance (MR) solution, after receiving 510(k) clearance by the US Food and Drug Administration (1). The solution aids in the process of prostate magnetic resonance imaging (MRI) reporting from visualization to quantification with the aim of increasing diagnostic accuracy and, potentially, early prostate cancer detection, which may contribute to long term survival.

This groundbreaking solution will more efficiently provide information to aid in the diagnose of prostate cancer, the second most common cancer in men annually effecting  1.4 million globally.  With nearly 1 in 8 men diagnosed with the disease during a lifetime, early detection is important but a challenge for oncologists as early-stage prostate cancer is asymptomatic. Current diagnostic tools like measuring prostate-specific antigen (PSA) in blood have known limitations and may result in patients undergoing invasive biopsies or even unnecessary surgeries.

Quibim set out to transform prostate diagnosis and monitoring by developing a new non-invasive imaging tool using MRI data and advanced computer models to investigate the prostate anatomy in extreme detail. Quibim's new qp-Prostate is the only tool on the market providing automated regional organ segmentation, a process that may reduce interpretation time and helps define diagnosis per region. "We challenged ourselves to build the world's finest AI platform for prostate imaging, to help increase diagnostic precision as a tireless companion to the clinician, helping transform the men's care journey," said Dr. Angel Alberich Bayarri, CEO Quibim. "Instead of analyzing the prostate as a whole, the solution can segment the prostate's transitional zone, peripheral zone and seminal vesicles, as well as other regions defined in the Prostate Imaging Reporting and Data System (PI-RADS) v2.1 guidelines to extract clinically meaningful quantitative information from the MRI examination as a potential aid for early and accurate clinicians' diagnosis."

Quibim has been at the forefront of the medical imaging industry for years and envisions that non-invasive prostate MRI's will become a routine screening test, similar to mammography for breast cancer. "MRI is the perfect modality for prostate evaluation, however, only 5% of radiologists are trained to interpret prostate MRI data," explained Prof. Luis Martí-Bonmatí, Quibim co-founder. "qp-Prostate shortens the learning curve and reduces the workload for radiologists, potentially increasing productivity by reducing image reading time and generates more meaningful insights for patient diagnosis and monitoring." He added, "We have worked closely with the FDA and are delighted that the device is now available in the US market."

Reporting is also accelerated with qp-Prostate's automated rules engine, allowing an end-to-end workflow. Reports can be sent to the Picture Archive and Communication System (PACS) instantaneously and synced with a patient's folder, so that complete medical information is available to radiologists at any time. Users can edit the standard PI-RADS v2.1 templates and re-launch any analysis if deemed necessary.

(1): qp-Prostate is specifically indicated as an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data."

About Quibim
Quibim, a company with its headquarters in Valencia, Spain, is a global leader in whole-body medical imaging analysis. Quibim products are used worldwide by leading research teams. Partners use Quibim Precision^®, a whole-body imaging ecosystem, for a wide range of applications from detecting a disease to tracking the efficacy of novel treatments.

Quibim follows an AI-first approach to help detect pathologies across every body part and imaging modality, using quantitative imaging biomarkers. We understand every body part. We speak human.

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