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)....
FDA: Approval for Novel Medical Devices Remains a High Priority, Despite COVID-19
According to the FDA’s Center for Devices and Radiological Health (CDRH) Annual Report, in addition to its significant efforts to fast track the approval of COVID-19 related devices, the CDRH...
