Article source: Sean Whooley, Medical Design & Outsourcing; Image source: Media from Wix
Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.
Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.