Brightheart is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Brightheart - FDA 510(k) Cleared Devices
Recent clearances: Fetal EchoScan (v1.2), BrightHeart View Classifier, BrightHeart View Classifier
5
Total
5
Cleared
0
Denied
Brightheart has 5 FDA 510(k) cleared medical devices. Based in Paris, FR.
Latest FDA clearance: Dec 2025. Active since 2024. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Brightheart Filter by specialty or product code using the sidebar.
2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Brightheart
5 devices