RhythMedix® Announces FDA Clearance, U.S. Launch of RHYTHMSTAR® Mobile Cardiac Monitoring System
SEPTEMBER 17, 2014,
MOUNT LAUREL, NEW JERSEY
RhythMedix, a developer of wireless healthcare solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its RHYTHMSTAR® Mobile Cardiac Monitoring System. The RHYTHMSTAR system is the first cloud-based, all-in-one patient monitoring solution to assist physicians in timely and accurate diagnoses of cardiac abnormalities. The FDA clearance allows RhythMedix to provide RHYTHMSTAR to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.
“The RHYTHMSTAR Mobile Cardiac Monitoring System represents a new approach in noninvasive, ambulatory arrhythmia monitoring,” said Phil Koren, M.D., Deputy Medical Director of the Cooper Heart Institute at Cooper University Health Care of Camden, New Jersey. “By incorporating sophisticated, real-time arrhythmia analysis algorithms with a patient friendly, single-component, wireless monitor, the RhythmStar® results in excellent arrhythmia documentation capabilities.”
Recognizing that heart abnormalities are sporadic and intermittent, RHYTHMSTAR monitoring provides up to 30 days of continuous monitoring in an ambulatory setting – empowering clinicians to diagnose and treat the most difficult-to-detect cardiac arrhythmias. The device continuously records multi-channel ECG and activity level data and, upon detection by an advanced algorithm or on-demand when a patient experiences cardiac symptoms, automatically delivers the recorded cardiac activity to the cloud-based system via cellular network. After review by the RHYTHMSTAR monitoring center staff, the relevant arrhythmias are promptly provided to the ordering physician for further analysis.
The RHYTHMSTAR Mobile Cardiac Monitoring System is flexible and enables healthcare providers to quickly deploy and manage a scalable and cost-effective patient monitoring solution. The cloud-based Software as a Services (Saas) model keeps the focus on monitoring rather than faulty hardware, network issues, or database administration. The featherweight, wireless 3G monitor transmits the patient’s heart signal to the secure and centrally managed ECG data repository that provides durable storage, geographical redundancy, and disaster recovery solutions for any sized operation.
RHYTHMSTAR monitoring offers physicians leading edge diagnostics supported by a central monitoring center that provides prompt delivery of detailed clinical reports and real-time alerts of critical health events. Services are strengthened by a dynamic team of highly trained certified cardiovascular technicians who attend to the every need of each referred patient. The RHYTHMSTAR monitoring center has been approved by the Center for Medicare & Medicaid Services (CMS) as an Independent Diagnostic Testing Facility (IDTF). In addition to Medicare, RhythMedix has also received approval from several commercial insurers, enabling the means for the RHYTHMSTAR Mobile Cardiac Monitoring System to be available in the United States.
RhythMedix® is committed to the advancement of remote patient monitoring. Combining innovative technology and a leading edge monitoring center, RhythMedix allows physicians to review and respond rapidly to clinically relevant patient health information—anytime, anywhere. For more information please visit www.rhythmedix.com.