Empatica S.r.l. FDA Approvals

0 new drug approvals and 7 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
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal510(k)Aug 14, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 14, 2026
EmbraceMini510(k)Dec 22, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2025
EpiMonitor510(k)Jun 19, 2025Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jun 19, 2025
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal510(k)Jun 6, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 6, 2025
EpiMonitor510(k)Feb 15, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 15, 2024
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal510(k)Oct 30, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 30, 2023
Empatica Health Monitoring Platform510(k)Nov 20, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 20, 2022