The ISO 13485 certification validates Ibex Medical Analytics’ position as a leading and quality-focused solution provider for healthcare organizations
Tel Aviv, Israel - November 5, 2020 - Ibex Medical Analytics, a pioneer in artificial intelligence (AI)-powered cancer diagnostics, today announced that it has received ISO 13485 certification. Obtaining the certification signifies that Ibex meets the most stringent quality standards and regulations for medical devices. The ISO certification comes as a culmination of Ibex’s diligent implementation of a quality management system and associated processes followed by a third-party audit, to ensure the safety and efficacy of its algorithms and solutions.
Ibex helps pathologists and healthcare providers improve cancer diagnoses, operational efficiencies and health economics by increasing diagnostic accuracy, enabling 100% quality control and reducing turnaround times and operating costs.
Pathology is the medical specialty of diagnosing disease and plays a pivotal role in cancer diagnosis and treatment decisions. 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 pathology institutes 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. Deployed worldwide, Ibex’s Galen™ Breast and the CE-marked Galen Prostate are the first-ever AI-powered cancer diagnostics solutions used in routine clinical practice in pathology, with demonstrated success in detecting missed cancer cases.
“We are proud to have gained the ISO 13485 certification,” said Daphna Laifenfeld, PhD, Ibex Medical Analytics Chief Scientific Officer. “Alongside the CE-IVD mark that Ibex obtained for our Galen™ Prostate solution, this demonstrates the high standards and commitment to quality that we employ during the design and utilization of our clinical-grade solutions. This certification is an important milestone for Ibex, at a time when the growing potential that AI and digital pathology offers pathologists who are struggling to meet the growing demand for cancer testing is becoming more and more apparent.”