Quebec City-based Icentia Inc. has announced that it has received U.S. FDA 510(k) clearance for CardioSTAT, an ambulatory continuous ECG monitoring offering that relies on a wire free, single-use recorder.
“This approval marks a key milestone for our company,” said Pierre Paquet, company co-founder and chief executive officer. “The FDA clearance opens the door to the world’s largest medical device market.”
To date, CardioSTAT has been prescribed for more than 170,000 patients. With this clearance, Icentia said it will be able to pursue its “mission of becoming a world leader in ambulatory cardiac monitoring.”
