Matthew Ruth

Jun 5, 2024 | jdsupra.com | Matthew Ruth

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 a statement of intent for what could be a significant shift in policy: approval to market and sell medical devices based on prior approval from a comparable regulatory country (CRC).

Dec 14, 2023 | jdsupra.com | Matthew Ruth

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).

Dec 14, 2023 | lexology.com | Matthew Ruth

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).

Jun 26, 2023 | ttgmedia.com | Matthew Ruth

You see, over the past few months, I’ve been using AI to help me, mainly ChatGPT and BingAI – both of which are free and easily available. And I’ve got to tell you, the results have been quite poor. But they will improve in the future, and for the next five perhaps even 10 years, I believe these tools will be of increasing benefit to the agent. More so than to the customer, in fact. We’ve been here before, of course. The web was going to replace agents, remember?

Jun 2, 2023 | jdsupra.com | Philip Nelson |Matthew Ruth

(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 Act (FD&C Act) , addressing concerns over the cybersecurity of medical devices.