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Brightheart FDA Approvals
0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Fetal EchoScan (v1.2)510(k)Dec 8, 2025Radiology |
| BrightHeart View Classifier510(k)Jun 5, 2025Radiology |
| BrightHeart View Classifier510(k)May 7, 2025Radiology |
| Fetal EchoScan (v1.1)510(k)May 2, 2025Radiology |
| Fetal EchoScan510(k)Nov 14, 2024Radiology |