The FDA granted a De Novo request for DreaMed Diabetes' artificial intelligence-based decision support software Advisor Pro, the Israeli diabetes management solutions developer confirmed June 18.
Advisor Pro analyzes patient data from continuous glucose monitoring, self-monitoring blood glucose and insulin pump devices to generate personalized insulin delivery recommendations. These recommendations are meant to help healthcare providers manage treatment for patients with Type 1 diabetes.
The FDA decision marks DreaMed Diabetes' second regulatory approval this year. The company received the European Union's CE Mark in February.