BrightHeart, a developer of artificial intelligence (AI) solutions for obstetrics and paediatric cardiology, has secured 510(k) clearance for its B-Right Views software from the US Food and Drug Administration (FDA).
This software automatically identifies necessary views during second and third-trimester foetal heart ultrasound evaluations, ensuring complete and consistent documentation irrespective of operator experience.
Last November, BrightHeart received initial FDA clearance for its B-Right Screen AI software, designed to flag structural markers suggestive of congenital heart defects (CHDs) during second-trimester ultrasounds. This month, further clearance allowed platform expansion, enabling clinicians to access AI feedback through a cart-side tablet.
The latest approval for B-Right Views enables comprehensive feedback on foetal heart documentation and flags potential severe CHD markers.
Additionally, BrightHeart has secured approval for its Predetermined Change Control Plan (PCCP), allowing it to implement pre-authorised improvements without needing separate FDA submissions. This strategic alignment enables efficient product enhancements and accelerates clinical impact across various settings.
BrightHeart board chairman Mike Butchko said: “As the industry rapidly shifts to one that is AI-enabled, BrightHeart is at the leading edge of innovation and poised to transform how ultrasound care is delivered globally.
“This milestone also reflects the exceptional execution of the team, delivering multiple clearances in record time.”
Based in Paris, BrightHeart is part of the Sofinnova MD Start accelerator by Sofinnova Partners. The company leverages advanced AI technology to analyse foetal heart ultrasound exams, supporting clinicians and sonographers in improving evaluations.
With three clearances in place and the PCCP established, BrightHeart is preparing for a limited market release following a successful pilot programme. The release aims to introduce the integrated solution to select clinics while inviting collaboration from clinicians, researchers, and industry leaders to advance maternal-foetal health.
