VivaQuant Receives FDA 510(k) Clearance for its RX-1 Rhythm ExpressTM Arrhythmia Device

ST. PAUL, Minn.--()--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, PhD, 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!”

About VivaQuant
VivaQuant is a digital health company using its Rhythm ExpressTM platform to analyze and report information from continuous ambulatory ECG recordings. We are addressing two markets, a $750M opportunity to provide Remote Cardiac Monitoring Services to clinics and hospitals for cardiac arrhythmia assessment and a $150M opportunity to provide ECG Research Services to the pharmaceutical and medical device industry to assess cardiac safety and efficacy. The key enabler of the accuracy and efficiency of Rhythm Express is our patented (22 issued) MultiDomain Signal Processing (MDSPTM) wavelet-based analytics. MDSP removes up to 95% of noise in ambulatory ECGs without distorting morphology, providing superb ECG clarity, improving arrhythmia detection accuracy, and reducing variability of cardiac interval measurements. Not only is MDSP accurate, it is computationally efficient, enabling a two-week battery life in our RX-1 device without a recharge. MDSP development has been supported by $1.7M in highly-competitive small business grants from the National Institutes of Health.

Contacts

Brian Brockway
bbrockway@vivaquant.com

Contacts

Brian Brockway
bbrockway@vivaquant.com