iRhythm wearable cardiac monitor gets CE mark, CardioLogic partners to sell it in U.K.

The Zio XT Patch--Courtesy of iRhythm

iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.

The Zio Service has long been FDA-approved. Since its launch in 2011, more than 250,000 patients at almost 1,000 U.S. institutions have used it.

CardioLogic and iRhythm are betting that the U.K.'s National Institute for Health and Care Excellence (NICE) will sign off on paying for the Zio service. NICE recently released new guidelines to improve treatment for patients with atrial fibrillation, the partners noted. Atrial fibrillation affects about 800,000 people in the U.K., with another potential roughly 250,000 in that country who remain undiagnosed. Financial terms of the deal remained undisclosed.

Martyn Dixon

"The first step in providing patients with proper treatment for Afib is to ensure that they are properly diagnosed," Martyn Dixon, managing director of CardioLogic, said in a statement. "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."

The system uses the Zio XT Patch, which records and stores all continuous electrocardiography (ECG) waveforms. It can be worn for up to 14 days and subsequently is returned to the company to retrieve the data and analyze it. The physician then receives a report on the results. iRhythm made the FierceMedicalDevices' 2014 Fierce 15 list, which examined some of the year's most intriguing and innovative companies.

"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," continued Dixon. "We believe that, with strong data backing its clinical validity and clinical utility, there will be great demand for the Zio Service among patients, physicians and hospitals in the U.K."

- here is the release

Special Report: FierceMedicalDevices' 2014 Fierce 15

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