Matthew Ruth

Knobbe Martens

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UK Proposes Approving Medical Devices Based on Approval in Other Countries

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more

6/5/2024 / Australia , Canada , EU , Food and Drug Administration (FDA) , Labeling , Medical Devices , Medicines and Healthcare Products Regulatory Agency (MHRA) , UK

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...more

12/14/2023 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA Updates Cybersecurity Guidance

(May 30, 2023) Going forward, medical device approval will require the device maker to provide cybersecurity information to the FDA. Congress made this change by adding Section 524B to the Federal Food, Drug, and Cosmetic...more

6/2/2023 / Cybersecurity , Data Privacy , Data Protection , Food and Drug Administration (FDA) , Health Insurance Portability and Accountability Act (HIPAA) , Medical Devices , Popular

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