Cardiac monitoring company Rhythmedix Inc. reported the launch of its next-generation, wearable Rhythmstar device with built-in 4G cellular connectivity. The low-profile, water-resistant cardiac telemetry monitor provides extended remote monitoring to quickly detect arrhythmia without the need for a phone or other communication device.

An estimated 33.5 million people worldwide have heart arrhythmias, doubling their risk of death. Yet while more arrhythmias are being detected with remote cardiac monitoring, patient compliance and timely access to heart output data limit diagnosis.

“Delayed patient data increases response time and prevents prompt clinical intervention,” Brian Pike, Rhythmedix’s co-founder, president and COO, told BioWorld. “Additionally, with competitive monitoring devices, patients are burdened by multiple cumbersome devices, chargers, sensors and device connections that can negatively impact patient compliance.”

Focus on at-risk patients

With a built-in rechargeable battery, Rhythmstar offers Holter, event and mobile cardiac telemetry (MCT) monitoring in a single wearable device – the only wearable to offer all three, according to the company.

The device is intended as an end-to-end cardiac monitoring solution, continuously and discretely connecting patients and clinicians, enabling streamlined patient care via real-time reporting and easier triage. Patients can record up to 30 days of heart activity, and the device can store 10 years of data on an embedded flash drive.

The cloud-based system leverages a rapid, two-step verification process that is backed by proven algorithms. A 24/7 monitoring center comprised of U.S.-based certified technicians rapidly reviews patient data and alerts physicians if a worrisome arrhythmia is detected.

The built-in cellular connectivity is also unique for a wearable cardiac monitor, Pike said. “Continuous 4G connection allows a physician to confirm patient compliance, verify the quality of the cardiac data being captured and potentially diagnose an arrythmia faster.”

Rhythmstar is also available with Hearttime on-demand telemetry mode, which lets doctors evaluate heart activity in real-time via telemedicine, reducing the need for in-person office visits.

Mount Laurel, N.J.-based Rhythmedix received U.S. FDA clearance for its first-generation, wired Rhythmstar system in 2014. The wearable device fell under a “letter to file,” Pike said. Both versions are covered under existing CPT codes for MCT, event and Holter monitoring.

Available nationwide

“We are excited to offer physicians and their patients our unique monitoring solution that improves patient compliance, helps accelerate diagnosis and allows patients to stay virtually connected to their patients with on-demand access to clinical data,” Pike said. “We look forward to bringing this next-generation Rhythmstar technology to physicians across the U.S. in 2021.”

The new device is available for commercial distribution across the U.S. “Our targeted rollout is focused on the East Coast. However, we’re already enrolled and [have] started service in the California, Illinois and Texas markets,” Pike said. “Demand for the device has exceeded expectations, and we see this increasing as we execute our marketing strategy in print, meetings and social channels.”

Looking ahead, Rhythmedix’s pipeline includes additional electrodes and sensor applications. “With the resurgence of telehealth, and more importantly, connectivity to the patient, the ability for a physician to remain ‘simply connected’ will play a vital role in our innovation plan,” Pike said.

Competition in cardiac monitoring

Rhythmstar is flanked by other players in the wearable cardiac monitoring space. Earlier this month, Israel-based Cardiacsense Ltd. reported CE mark approval of its medical watch for the detection of atrial fibrillation and heart variability monitoring. The company received marketing approval of the medical-grade watch by Israeli regulators in August 2020 and anticipated FDA clearance in the third quarter of 2021. It does not require a prescription for use in European markets.

Withings SA, of Issy-les-Moulineaux, France, launched Scanwatch, which detects both atrial fibrillation and sleep apnea, in Europe in 2020 following the receipt of CE marking. U.S. FDA clearance is pending. Atrial fibrillation and sleep apnea are often associated and can be precursors of more serious health problems such as heart attack and stroke.

And in January, Boston Scientific Corp. announced plans to buy Preventice Solutions Inc. in a deal worth up to $1.2 billion. Preventice, of Minneapolis, offers a broad portfolio of mobile cardiac health solutions and services, including the Bodyguardian family of remote, wearable cardiac monitors for adult and pediatric patients.