BrightHeart’s B-Right Views Receives FDA Clearance for CHD Detection

BrightHeart, a global provider of artificial intelligence (AI) solutions in obstetrics and paediatric cardiology, has received its third 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest innovation, B-Right Views. 

This development marks another step forward in the company’s efforts to support prenatal care with advanced AI tools.

B-Right Views is designed to help clinicians during second and third-trimester fetal heart ultrasound exams. 

The software automatically detects and confirms when all the standard views required for the exam are captured, ensuring consistent and complete documentation regardless of the clinician’s level of experience.

With this latest approval, BrightHeart now offers the first integrated AI solution that both guides sonographers in capturing the correct fetal heart views and highlights structural markers suggestive of severe CHDs.
 
This combination addresses a complex area of obstetric imaging by improving both diagnostic accuracy and workflow efficiency.

The PCCP is expected to help BrightHeart enhance its platform more efficiently and adapt quickly to clinical needs.