Rhythm AI, Ltd. 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
STAR Apollo Mapping System510(k)Dec 19, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Dec 19, 2025
STAR Apollo Mapping System510(k)Jul 26, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024