Cardiac Monitors in Georgia

Huxley Medical, Inc. develops FDA-cleared wearable diagnostic patches and cloud-based software platforms for integrated cardiosleep assessment. The company's flagship product, SANSA® (Sleep Apnea and Nocturnal Symptom Assessment), is a single-use, wireless, cellular-enabled patch that captures nine channels of physiological data—including ECG, SpO2, heart rate, respiratory effort, chest movement, body position, actigraphy, snoring, and sleep/wake staging—to diagnose obstructive sleep apnea and detect cardiac arrhythmias including atrial fibrillation in a home-based setting. SANSA® has received FDA 510(k) clearance for sleep apnea testing, diagnostic ECG capabilities, and central sleep apnea detection. The device has been validated in multi-site clinical trials against gold-standard polysomnography (PSG). Huxley's software platform, Huxley HUB™, is a HIPAA-compliant cloud portal offering real-time data management, epoch-by-epoch sleep review, AI-powered auto-scoring at 3% and 4% hypopnea thresholds, customizable reporting templates, and direct report delivery to sleep specialists and cardiologists. The company targets sleep medicine practices, cardiology clinics, and primary care settings seeking to streamline sleep apnea diagnosis, reduce diagnostic backlogs, and integrate cardiosleep assessment without lengthy referrals or multiple in-clinic visits. SANSA Express™ offers direct-to-patient shipping with 24/7 live support. Regulatory credentials include FDA 510(k) clearance and HIPAA compliance. Manufacturing and service capabilities include cellular-enabled wearable patch design, cloud-native platform architecture, and direct patient logistics.

Mespere LifeSciences Inc. is a medical device innovator specializing in non-invasive, integrated hemodynamic monitoring solutions for cardiac and cerebral applications. The company develops advanced technologies for continuous, noninvasive monitoring of cardiac and neurological parameters, enabling real-time assessment of patient perfusion and hemodynamic status. Their product portfolio includes the Perfusion M system, designed to provide clinicians with integrated cardiac and cerebral monitoring capabilities without invasive procedures. Mespere's solutions are positioned for use in acute care, critical care, and perioperative settings where hemodynamic monitoring is essential for patient management and clinical decision-making. The company focuses on technology innovation in the patient monitoring segment, with emphasis on noninvasive methodologies that reduce procedural risk and improve patient comfort while maintaining clinical accuracy. Regulatory status and specific product certifications were not evident in the available content.

Artivion is a specialized cardiovascular medical device company focused exclusively on aortic and cardiac surgery solutions. The company manufactures and markets a comprehensive portfolio of devices for treating aortic diseases, aortic dissections, and cardiac valve disorders. Product lines include mechanical and biological heart valves (ON-X Aortic and Mitral Valves, CRYOVALVE allografts), aortic arch solutions (AMDS Hybrid Prosthesis, E-VITA OPEN NEO, NEXUS stent graft systems), thoracoabdominal and abdominal aortic stent grafts (E-TEGRA, E-LIAC, E-NSIDE TAAA), peripheral aortic devices, and ancillary surgical solutions including BIOGLUE surgical adhesive and decellularized pericardium (PHOTOFIX). Artivion recently acquired Ascyrus Medical in 2020, expanding its aortic arch offerings. The AMDS Hybrid Prosthesis, developed for acute DeBakey Type I aortic dissections, received FDA Humanitarian Device Exemption (HDE) in December 2024 and is supported by the PERSEVERE pivotal clinical trial. Products are regulated through FDA 510(k) clearances and PMA pathways, with multiple investigational device exemptions (IDEs) active. The company collaborates with cardiac and vascular surgeons worldwide and supports clinical evidence generation through real-world post-market studies and pivotal trials. Artivion serves hospitals, surgical centers, and cardiac/vascular surgery programs globally, with particular emphasis on advanced aortic interventions and valve replacement technologies.

Zywie, Inc. is a remote cardiac monitoring company delivering next-generation mobile cardiac telemetry (MCT) solutions for arrhythmia detection and continuous heart rhythm monitoring. The company manufactures the ZywieNano™ MCT Patch, a miniaturized biosensor worn as a patch for up to 30 days of continuous ECG monitoring. Core offerings include the patch device, a proprietary mobile application for patient engagement, AI-driven rhythm analysis (ZywieAI®), near real-time data transmission to clinicians, and 24/7 patient support services. The platform targets cardiology practices, primary care providers, and patients with suspected or known cardiac arrhythmias, atrial fibrillation, and syncope. Zywie's technology enables extended monitoring periods (15–30 days) versus traditional Holter monitors (24–48 hours), with integrated event logging, symptom tracking, and clinical decision support. The system provides advanced rhythm analysis including detection of ventricular tachycardia, atrial fibrillation, pauses, and bradycardia. The company serves 500,000+ patients and has processed over 1 trillion heartbeats. Regulatory status, specific FDA clearance details, and ISO certifications are not explicitly stated on the website. Zywie operates corporate headquarters in Johns Creek, Georgia and a clinical headquarters in Walnut Creek, California.