FDA Designates Anumana’s Pulmonary Hypertension Software a Breakthrough Device

The FDA has granted Anumana’s artificial intelligence (AI) software for analysis of electrocardiogram (ECG) data a Breakthrough Device designation.

The Pulmonary Hypertension (PH) Early Detection Algorithm is a screening tool that offers early diagnosis of patients with pulmonary hypertension, which can often go unnoticed until the disease has advanced. The company developed the algorithm in collaboration with Johnson & Johnson subsidiary Janssen and the Mayo Clinic.

The software analyzes data from 12-lead ECGs in primary care, urgent care and emergency room settings. It uses an AI software platform developed by Anumana’s parent company, nference, which contains more than 6 million de-identified patient records.