Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeIbex Medical AnalyticsIbex Obtains CE-IVD Mark for Galen™ Prostate Solution

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

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 is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy