Ibex Medical Analytics Announces IVDR Certification for HER2 Biomarker Scoring Solution in Breast Cancer
(NASDAQ:IBIO) BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its HER2 breast cancer biomarker scoring solution. Ibex’s fully automated “zero-click” AI-enhanced decision support tool for pathologists efficiently increases the accuracy and consistency of HER2 immunohistochemistry (IHC) scoring, including HER2-low cases. Ibex’s brea
Related Questions
What is the expected timeline for commercial rollout and revenue generation from the newly certified HER2 scoring solution?
How does Ibex's IVDR certification position it against existing competitors in AI-powered pathology diagnostics, and could it lead to incremental market share?
Will the IVDR certification enable further regulatory clearances (e.g., FDA) or expand geographic market access, and how might that affect the company's growth outlook?