RhythMedix, LLC - FDA 510(k) Cleared Devices

RhythMedix, LLC is a U.S.-based cardiac monitoring company founded in 2013. The company develops wearable cardiac monitoring devices with integrated cellular connectivity for arrhythmia detection and management. RhythMedix operates with a fully integrated model combining device technology, manufacturing, software, and 24/7 clinical monitoring services.

The company has received 3 FDA 510(k) clearances from 3 total submissions since 2014. RhythMedix specializes exclusively in Cardiovascular devices, with its primary product line focused on remote cardiac monitoring systems. The latest clearance was granted in 2026, confirming the company remains active in device innovation and regulatory compliance.

RhythMedix's core offerings include extended-wear Holter monitors and outpatient cardiac telemetry systems featuring proprietary Augmented Arrhythmia Intelligence technology. These devices deliver rapid ECG analysis and clinician notification through continuous monitoring and expert clinical oversight. The company maintains a U.S.-based monitoring center staffed by certified cardiac technicians and operates with Medicare certification and Joint Commission accreditation.

For detailed information on specific device names, product codes, and individual clearance dates, consult the FDA 510(k) database or contact the company directly.

510(k) submissions have been managed by MethodSense, Inc. as regulatory consultant.