FDA Clears VivaQuant’s RX-1 Wearable Rhythm Express Arrhythmia Device

VivaQuant, a digital health company with powerful technology to accurately and efficiently identify and report cardiac arrhythmias, has received FDA clearance for its RX-1 wearable device.
 
RX-1 continuously monitors a patient’s ECG as they go about their normal daily activities, identifies arrhythmias, and communicates the information to the cloud using a built-in cellular connection. Skilled staff in a US-based monitoring center review the incoming data and report clinically important information to the patient’s physician.
 
RX-1 employs VivaQuant’s patented wavelet-based analytics and embedded artificial intelligence to extract information more quickly, accurately, and efficiently than traditional technologies. The result is high-quality cost-effective arrhythmia monitoring services for patients with cardiac disease. RX-1 is a small, easy to wear, one-piece device that can be worn in the shower. It can operate as a mobile cardiac telemetry device, event recorder, or Holter monitor. VivaQuant’s cardiac arrhythmia diagnostic products are sold under the Rhythm ExpressTM brand.
 
“RX-1 represents a new standard for arrhythmia reporting accuracy, efficiency, and ECG signal clarity,” says Marina Brockway, Ph.D., VivaQuant’s founder and chief technology officer. “Because ECG clarity is so good and arrhythmia detection so powerful, we believe that RX-1 will provide faster, higher-quality diagnosis, at a lower cost.”
 
John Collins, Director of Marketing for the Rhythm Express product line and former Medtronic CRM product manager adds, “We are extremely excited to introduce this breakthrough technology and partner with customers who are striving to improve patient diagnoses and reduce costs. The Rhythm Express technology and our partnering business model will surely be a great fit for customers. This is going to be a fun and rewarding product launch!”