Australia's CardieX climbs after US FDA classifies app as medical device data system

Conneqt Health

18/05/2022 03:29

** Shares of medical device maker CardieX  CDX.AX  soar as
much as 21% to A$0.375 in their best intraday session since
April 29
    ** Co says its CONNEQT Companion App, which integrates into
CONNEQT Pulse, its home-use dual blood pressure management
device, has been classified by the U.S. FDA as a medical device
data system (MDDS)  urn:newsml:reuters.com:*:nASX6jMCYD 
    ** The classification as an MDDS as opposed to an accessory
to a Class II medical device means co has flexibility to launch
the app without a separate approval process for it, subject to
FDA clearance of the device 
    ** Stock hits highest level since May 6
    ** Stock down 55.1% this year, as of last close

 (Reporting by Harshita Swaminathan)
 ((Harshita.Swaminathan@thomsonreuters.com))