Mycardium AI Limited 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	What it is	Route	Decided
EchoConfidence (USA)510(k)Jun 30, 2025Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Jun 30, 2025
1CMR Pro510(k)Nov 15, 2024Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Nov 15, 2024