Icentia receives U.S. FDA clearance for CardioSTAT

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.”

Would you recommend this article?


Thanks for taking the time to let us know what you think of this article!
We'd love to hear your opinion about this or any other story you read in our publication.

Jim Love, Chief Content Officer, IT World Canada

Featured Download

CDN in your inbox

CDN delivers a critical analysis of the competitive landscape detailing both the challenges and opportunities facing solution providers. CDN's email newsletter details the most important news and commentary from the channel.

Big Bytes

Related Bytes