FDA clears Curvus wireless ECG monitor

By: Brian Dolan | Dec 15, 2010        

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CurvusThe US Food and Drug Administration (FDA) has granted 510(k) regulatory clearance to the Curvus Arrhythmia Monitoring Device (C-AD), a wireless-enabled and continuous tracker of real-time ECG readings. Curvus is a subsidiary of WPR Medical, which is based in Norway. C-AD will enter the market where a handful of other wireless cardiac monitoring companies are already playing: CardioNet, LifeWatch and the (recently FDA approved) Corventis Nuvant system among others.

It’s worth highlighting Curvus’ Norwegian roots. Interestingly, other Norwegian companies and entities have made mHealth related news in recent months, most notably the The Norwegian Agency for Development Cooperation, Norad, announced a $1 million grant to the mHealth Alliance last month. Norwegian mobile operator Telenor has also been actively piloting aging in place initiatives in the country.

Curvus’ offering — like other wireless ECG systems — includes three components: The sensors, the receiving/transmitting device, and the backend analytics.

The C-AD system uses a single-lead sensor with two electrodes and a mobile recorder that transmits via the unlicensed 2.4 GHz frequency. Curvus pitches the system as designed to facilitate “unencumbered cardiac monitoring of patients during the activities of daily living… because of its inconspicuous nature, the Curvus wireless solution also eliminates the stigma associated with wearing a Holter monitor.” According to Curvus, the sensor can operate for 72 hours without any user interaction.

The receiver is a handheld device that receives data streams from the sensors for “permanent storage and analysis of irregular events,” according to the company. The device runs over GSM/GPRS networks like AT&T or T-Mobile USA or via Bluetooth or “a wireless network,” (which likely means WiFi).

Curvus supports the monitor with a data analysis service that crunches ECG data using “clinically established arrhythmia parameters.”

Curvus originally began work on the system in 2003 when it created a prototype of the ECG sensor that demonstrated the device’s wireless design principles. In 2006 the company began clinical trials with patients. In 2007 Curvus began the commercial design phase of C-AD, according to the company’s corporate site.

“We are thrilled that Curvus has achieved regulatory clearance and can now be commercialized in the US,” Borge Bogaard, Chief Executive Officer of Curvus, stated in a press release. “Due to the rapidly increasing burden of atrial fibrillation worldwide, we believe that expanded monitoring and diagnosis of these cardiac events combined with the release of several new anticoagulant drugs, will make a major contribution to control the disastrous worldwide burden of stroke. With its 100 percent wireless design and ability to transmit clear, actionable data whether the patient is resting, running a marathon or showering, we believe Curvus is well-positioned to expand monitoring broadly.”

For more on the Curvus announcement, read the press release here (PDF)

  • David Albert, MD

    I think someone should tell them that you can get a 510(k) but all ambulatory ECG monitoring CPT codes (including MCT) require a minimum of two ECG leads. Their device is not reimbursable under current rules– that is a BIG problem for them.