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The FDA clarified its regulatory approach for multiple function devices in a final guidance that outlines the extra steps manufacturers of such products need to take. Read More
An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led to calls for major reforms at the agency due to its mishandling of safety concerns linked to pelvic mesh. Read More
The device and software platform “will help front line responders provide emergency care, diagnosis and treatment,” including defibrillation therapy and data management, the company said. Read More
The agency said the mock datasets will “support bringing safe products to market sooner” so patients can benefit from the latest technical advances. Read More