What BrightHeart Announced About Its CE Mark and European Launch
BrightHeart said on 8 July 2026 that it received a CE mark and is launching its B-Right AI platform across the European Union, with its European debut at the Fetal Medicine Foundation World Congress in Vienna held from 28 June to 2 July 2026. The company states that both B-Right Views and B-Right Screen are Class II FDA cleared and Class IIa CE marked, with notified body 3022.
Why the BrightHeart CE Mark Matters to Prenatal Ultrasound Buyers
Two approvals in two systems is the practical difference between a pilot and a product a European hospital group can buy. The two products are cleared and marked separately, so a buyer should check which one covers the job in front of them rather than treating the platform as a single permission. Neither approval says anything about how many heart defects the software will find in a particular clinic, which is a question for the evidence, not the paperwork.
Where the BrightHeart Update Comes From
BrightHeart is the original record behind this update. It tells us what the company published. This brief adds the market context and the method we would use to test the development against other evidence.
How We Would Research the BrightHeart CE Mark
The source gives us the starting point. This is how we would build the next layer of research around it.
- We would start by reading the CE certificate and the FDA clearance for each product separately, because the names are similar and the permissions are not the same.
- Then we would ask BrightHeart which European sites are live and go to those sonographers for what changed in their exam time.
- We would check how the software behaves when a view is incomplete, since an incomplete fetal heart exam is the real problem it claims to help with.