Anumana, Inc. FDA Approvals

0 new drug approvals and 6 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
WatchMate Software510(k)Jun 15, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 15, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)510(k)Apr 7, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 7, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)510(k)Mar 28, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 28, 2026
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)510(k)Jul 28, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 28, 2025
NeuTrace EP Mapping System v.2.1510(k)Nov 25, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 25, 2023
Low Ejection Fraction AI-ECG Algorithm510(k)Sep 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 28, 2023