Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data across multiple disease indications, the company reported. The approval will open up the market for digital health apps, with customers now able to link into Huma’s underlying technical platform to develop their own digital health apps and companion diagnostics, avoiding the need to then get their own, separate EU medical device certification.