Quebec-based medical technology company Icentia has secured US Food and Drug Administration (FDA) approval for CardioSTAT, a wire-free recorder that continuously monitors electrocardiogram (ECG) readings. With a compliance rate of 99.9%, CardioSTAT has been used by more than 170,000 patients to record up to two weeks of data. Physicians can opt for monitoring between 24 hours and 14 days with the recorder. Icentia CEO Pierre Paquet said the approval marked “a key milestone” that would allow the company to extend its market to the US.
The company also offers proprietary software that allows healthcare institutions and diagnostic facilities to read the data collected by CardioSTAT without requiring their own equipment. Icentia has already secured places in Canada and the UK. The device offers cost savings and the flexibility to address various clinical needs, with atrial fibrillation and long-term disability in the US targeted by the product.
Atrial fibrillation, a condition that affects between 1% and 3% of the world population, is responsible for more than 140,000 deaths in the US alone, according to the Stroke Awareness Foundation. Stroke is a leading cause of serious long-term disability in the country. With these concerns in mind, CardioSTAT aims to help US physicians detect heart anomalies, or atrial fibrillation, that are typically difficult to isolate.
Icentia has emerged as a leading company in this area in Canada, where its CardioSTAT device has been widely deployed. The device is both flexible and showerproof, making it comfortable for patients, while also delivering necessary readings to physicians. Units that run for over a week are used frequently, offering physicians a detailed insight into their patients’ ECG readings.
Due to the success already seen in Canada, as well as the positive adoption rate in the UK, Icentia is excited about the possibilities of entering the US market. The FDA clearance will allow the company to extend its operations across borders and meet the growing demand for a modern, trustworthy, and reliable cardiac monitoring solution for patients.
The CardioSTAT recorder is being seen as one of the most innovative solutions available on the market with physicians and patients rapidly adopting the technology. With the company’s commitment to improving cardiac monitoring and accessibility around the world, it will be interesting to see how CardioSTAT is received in the US. With stroke and long-term disability significant concerns for the healthcare industry, devices like the CardioSTAT could prove crucial in detecting and preventing heart-related issues.
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