Medical Device News Magazine

Ibex Obtains CE-IVD Mark for Galen™ Prostate Solution

Ibex's Galen™ Prostate solution Demonstrates Outstanding Results in a Blinded Study and Supports Pathologists in Providing Accurate Diagnosis, Enhanced Lab Efficiency and Quality Control

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

The company reports this is the first-ever AI-based solution for cancer detection used in routine clinical practice – is already deployed in pathology labs with demonstrated success in alerting on missed cancer cases. With this CE-IVD Mark of Galen Prostate, Ibex is now partnering with leading institutes across Europe to implement AI and support pathologists in their diagnostic workflow.

Pathology is the medical specialty of diagnosing disease in patients and plays a pivotal role in cancer diagnosis and treatment decisions. To this day, cancer diagnosis is performed by pathologists looking at biopsies through a microscope. In recent years, a global increase in cancer incidence and in the number of screening tests has coincided with a decline in the number of pathologists, causing a crisis that affects labs worldwide and results in longer turnaround times and rising concerns about diagnostic accuracy.

Ibex uses AI to develop clinical-grade solutions that help pathologists detect and grade cancer in biopsies, helping them ensure diagnostic accuracy, integrate comprehensive quality control and enable a more efficient workflow. Galen Prostate is a vendor-neutral AI solution, evaluated across multiple scanning systems, staining platforms and pathology labs. The solution uses an algorithm that was trained on slides from a dataset of over 60,000 prostate slides from multiple institutions and representing a variety of diagnoses and clinical findings.

The CE-IVD Mark follows the outstanding results from a blinded multi-site prospective clinical study measuring, for the first time, performance against consensus diagnosis between multiple pathologists. The study included digitized slides from prostate core-needle biopsies analyzed by Galen Prostate. Performance was evaluated against the consensus diagnosis of multiple pathologists. Ibex’s AI-powered algorithm demonstrated the highest AUC (area under the ROC curve) reported in the field, 0.997, as well as very high sensitivity and specificity (98.6% and 95.6%, respectively). These results validate the robustness of Galen Prostate and support its adoption by pathology institutes aiming to improve their diagnostic accuracy by enhancing quality control with AI.

“We are impressed with the results of the study, particularly with the performance of Galen Prostate, which was in near perfect concordance with the consensus diagnosis between multiple pathologists. This solution can become an important tool for pathologists that look for ways to improve diagnostic quality and workflow efficiency,” said Delphine Raoux, MD, Head of Innovation Technologies at Medipath – the largest network of private pathology labs in France, who participated in the study. “Medipath believes that AI-powered solutions are the future of pathology and we are happy to participate in trials that demonstrate their accuracy and utility, and to collaborate with Ibex to help the evolution of their AI solutions.”

“We hit an important milestone with the CE-IVD Mark, facilitating a wider adoption of Galen Prostate in the market. These clinical-grade results confirm our robust and meticulous approach to AI, that corresponds to the pathologist’s own workflow,” said Joseph Mossel, Ibex Medical Analytics CEO. “Cancer incidence and testing for cancer keep growing, with an impact on pathologists’ turnaround times and misdiagnosed cases. Ibex is committed to providing practical solutions that help pathologists meet these challenges.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.