FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment

ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The FDA’s Breakthrough Device Program is designed to speed up the development, assessment, review for premarket approval, 510(k) clearance, and de novo marketing authorization of medical devices “that provide for more effective treatment or diagnosis of life-threatening or…
By: Knobbe Martens