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# ABK Biomedical Gets Breakthrough Status
- URL: https://www.fdaweb.com/abk-biomedical-gets-breakthrough-status/
- Published: 2023-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:17:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155926

FDA has granted ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients living with unresectable hepatocellular carcinoma (HCC). The company recently initiated enrollment in Route90, its pivotal, prospective, multicenter trial to establish the safety and efficacy of Eye90 microspheres in the patient population with unresectable HCC. “This medical device allows us to leverage multi-modality imaging, facilitate controlled visual administration and offers personalized dosimetry,” the company says.