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Cogstate announces European approval for Healthcare offering

Cogstate announces European approval for Healthcare offering

Cogstate, today announced that its Healthcare Division has received CE Mark approval for its Cognigram™ digital cognitive assessment system.

June 4, 2018
Cogstate Announces First U.S. Deployment of the Cognigram™ System at the University of Notre Dame

Cogstate Announces First U.S. Deployment of the Cognigram™ System at the University of Notre Dame

Cogstate today announced the commercial deployment of its Cognigram™ digital cognitive assessment system at the University of Notre Dame. This placement represents the first Cognigram system commercial implementation in the United States, following the recent FDA notification that the Company can begin marketing the system in the U.S.

October 11, 2017
Cogstate receives positive FDA notification regarding medical device regulatory submission

Cogstate receives positive FDA notification regarding medical device regulatory submission

Cogstate today announced their FDA submission for the Cognigram system has been found to meet the requirements of regulations 21 CFR 882.1470; Class II Exempt Medical Device, allowing the company to market the medical device for commercial distribution in the U.S.

July 27, 2017