Exo, Inc. FDA Approvals

0 new drug approvals and 4 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
Lung AI (LAI001)510(k)Apr 24, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2025
Strain AI (SAI001)510(k)Nov 20, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 20, 2024
AI Platform (AIP001)510(k)Nov 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2023
Bladder AI (AIBV01)510(k)Jun 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 22, 2023