Icardio.Ai 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
CardioVision510(k)Nov 21, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 21, 2025
EchoMeasure510(k)Oct 10, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 10, 2024