Ibex Medical Analytics, a pioneer in artificial intelligence (AI)-powered cancer diagnostics, has received ISO 13485 certification, the company announced Thursday.
Obtaining the certification signifies that Ibex meets the most stringent quality standards and regulations for medical devices.
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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.
