Company profile

Brightheart

Brightheart has 5 AI-enabled medical devices on the FDA list. The first decision was on November 14, 2024 and the most recent on December 8, 2025 (Fetal EchoScan (v1.2)). Its most common review panel is Radiology (5 devices).

5AI devices
2024First decision
2025Latest decision
1Specialties

Per year

2024: 12025: 4
20242025
Brightheart AI devices per year: 2024 1, 2025 4

By specialty

  • Radiology5

Related guides

Top radiology devices

Timeline

  1. Fetal EchoScan (v1.2) · Radiology · POK
  2. BrightHeart View Classifier · Radiology · QIH
  3. BrightHeart View Classifier · Radiology · QIH
  4. Fetal EchoScan (v1.1) · Radiology · POK
  5. Fetal EchoScan · Radiology · POK