DEARhealth has gained a CE mark for its artificial intelligence-based patient care software for chronic disease management, making it one of the first software developers to obtain a CE mark for compliance with the EU’s Medical Device Regulation, which went into effect on May 26.

The company also obtained the ISO 13485 certification for medical device quality management systems.

The new certification will enable the company to “accelerate collaboration with health systems across Europe,” said Katinka de Korte, DEARhealth's regulatory compliance manager.

The company has installed the software in large healthcare systems to manage disease areas, such as inflammatory bowel diseases, epilepsy, rheumatology and ovarian cancer.