Paving the Way for Continuous Innovation: Navigating FDA PCCP Authorization for AI-Driven Medical Devices

Beacon Biosignals is a pioneer in the FDA’s latest guidance around machine learning and AI in medical devices. In 2024, Beacon Biosignals received two of the FDA’s 44 total Predetermined Change Control Plan (PCCP) authorizations, ensuring both their hardware and software products remain cutting-edge. In this webinar, we’ll unpack how AI/ML is reshaping medical devices and share practical strategies to navigate evolving regulations— including how to use a PCCP to release every two weeks, like Beacon Biosignals.