iRhythm Technologies receives CE mark for ZIO Service and enters UK partnership with CardioLogic


iRhythm Technologies has secured a CE mark for the ZIO Service, enabling the company to market its long-term continuous heart monitoring solution in Europe. The company also announced its first international market entry through an exclusive agreement with CardioLogic Ltd, which will make the ZIO Service available to patients throughout the UK to improve the diagnosis of atrial fibrillation and other cardiac arrhythmias.

CardioLogic will market the ZIO Service – which is powered by advanced wearable biosensing technology – to its network of cardiologists and institutions throughout the UK, beginning in December 2014. The ZIO Service is backed by multiple peer-reviewed, published studies and is already recognised as a new standard of care for diagnosing atrial fibrillation and other cardiac arrhythmias in the USA. Since its commercial launch in 2011, it has been used with over 250,000 patients at nearly 1,000 institutions nationwide.

The ZIO Service consists of three components that work together as a digital cardiac healthcare solution to enable more efficient and cost-effective diagnosis of cardiac arrhythmias. The ZIO XT Patch records and stores all continuous electrocardiography waveforms for analysis when required, facilitating the diagnosis of arrhythmias. Proprietary FDA-cleared algorithms are used to analyse the vast data and certified cardiac technicians then review the curated data. Finally, the secure, cloud-based ZIO Report provides physicians with unique, clinically actionable information to enable diagnosis, including the ruling in and ruling out of cardiac arrhythmias, to help guide treatment decisions.

The UK National Institute for Health and Care Excellence recently announced new guidelines to improve treatment for people with atrial fibrillation and thus reduce the risk of stroke. According to NICE, atrial fibrillation affects approximately 800,000 people in the UK and it is believed that another 250,000 people may be undiagnosed.

“The first step in providing patients with proper treatment for atrial fibrillation is to ensure that they are properly diagnosed,” says Martyn Dixon, managing director of CardioLogic. “Traditional monitoring techniques have been limited in their ability to detect cardiac arrhythmias because they do not capture enough information or for a long enough period of time. With its consumer-friendly biosensing technology and powerful analytics, the ZIO Service overcomes these limitations to improve diagnosis, with the potential to improve outcomes for the growing number of people affected with this heart rhythm disorder.”