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Heartbeam, Inc. FDA Approvals
0 new drug approvals and 2 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 |
|---|
| HeartBeam AIMIGo with 12-L ECG Synthesis Software System510(k)Dec 8, 2025Cardiovascular |
| HeartBeam AIMIGo(TM) System510(k)Dec 13, 2024Cardiovascular |