QUEBEC CITY, 6. April 2023 /PRNewswire/ — Icentia Inc. today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory continuous ECG monitoring solution based on a disposable wireless recorder. “This approval is an important milestone for our company. FDA approval opens the door to the world’s largest medical device market. “Given the cost-effectiveness of our cardiac monitoring solution and the ability of our cardiac monitoring to deliver effective patient care and outcomes, we have no doubt that CardioSTAT will make a significant difference in the diagnosis of heart disease patients in the United States,” he said. Stone packCo-founder and CEO of Icentia.
CardioSTAT is currently Canada’s leading portable cardiac monitoring solution. in the year In 2018 it was expanded to the United Kingdom, where it had an exceptional level of acceptance. To date, CardioSTAT has been prescribed to more than 170,000 patients. With this approval, ICENTIA will be able to continue its goal of becoming a global leader in ambulatory cardiac monitoring by expanding its market into the United States.