BrightHeart has achieved a significant milestone in obstetric and pediatric cardiology by receiving its third FDA 510(k) clearance, this time for its second AI-powered device, B-Right Views. This innovation marks the company as the first to provide an integrated solution that combines real-time fetal heart documentation with congenital heart defect (CHD) detection. The new software automatically identifies and confirms all standard views required during second and third-trimester anatomy scans, ensuring comprehensive fetal heart assessments regardless of the operator’s experience. The integration of this feature into routine ultrasound workflows represents a major leap in the application of AI to one of the most complex aspects of prenatal care.

The importance of this innovation lies in its potential to address long-standing challenges in fetal heart imaging. Historically, variability in sonographer experience and incomplete image capture have led to missed or delayed CHD diagnoses. By offering real-time feedback and view confirmation, B-Right Views can help reduce repeat scans, improve diagnostic accuracy, and provide earlier identification of high-risk cases. The FDA’s approval of BrightHeart’s Predetermined Change Control Plan (PCCP) further sets the company apart, allowing it to rapidly implement AI improvements without requiring separate regulatory submissions—accelerating innovation and clinical impact.