Holter Monitors in California

Datrix LLC is a commercial ambulatory ECG device manufacturer established in 1988 and incorporated as an LLC in 2017. The company designs, manufactures, and distributes Holter monitors and ambulatory cardiac monitoring devices to dealers and medical equipment companies globally. Primary products include the VX3 Holter Recorder, a traditional 3-channel device available in 5 or 7-wire configurations, and the Sirona, a versatile 4-in-1 ambulatory monitor supporting event, post-event, and Holter monitoring modes with configurable lead options or patch-based monitoring. Datrix maintains ISO 13485 certification and FDA registration for its manufacturing facility, ensuring compliance with FDA Quality Systems Regulations. The company leverages strategic relationships with ISO 13485-registered contract manufacturers in Asia to support its production capabilities. Quality systems emphasize design and process validation, equipment qualification, lot traceability, and compliance testing, with continuous improvement through Lean Manufacturing practices. Datrix serves the ambulatory cardiac monitoring segment, supporting clinical requirements for long-term heart rhythm monitoring in diverse care settings.

LifeSignals, Inc. is a medical device company specializing in wireless patient monitoring solutions and disposable wearable biosensors for in-hospital, hospital-at-home, and ambulatory care settings. The company develops the UbiqVue™ platform, a cloud-based wireless patient monitoring system that captures continuous vital signs including 2-channel ECG and multiparameter vital signs through single-use, cost-effective biosensors. LifeSignals' patented LSP silicon platform enables disposable sensors designed for mass production, reducing clinical device costs while maintaining clinical-grade accuracy. The UbiqVue Multiparameter system provides near real-time vital sign monitoring for large-scale in-hospital and hospital-at-home delivery; the UbiqVue Holter system delivers cloud-based ECG analysis and reporting for ambulatory cardiac services and mobile cardiac telemetry (MCT). Core technology includes Wi-Fi-centric wireless connectivity with support for multiple radios, HIPAA and GDPR-compliant data transfer, and robust encryption. The company serves healthcare providers, integrated delivery networks, and digital health platforms seeking to untether patients from wired monitoring constraints while enabling data-driven clinical insights. LifeSignals operates manufacturing and integration capabilities with headquarters in Milpitas, CA, and regional offices in India, Europe (Ireland), and Asia-Pacific (Singapore), supporting global deployment of wireless healthcare monitoring infrastructure across population health initiatives.

EdanUSA is a San Diego-based distributor and service center for FDA-approved diagnostic medical equipment, established in 2009 to provide U.S. local support and inventory. The company stocks over $1 million in diagnostic equipment and spare parts, serving over 100 resellers across the United States. EdanUSA specializes in high-quality, cost-effective diagnostic devices including patient monitors, ECG/EKG machines, ultrasound systems, fetal monitors, Holter monitors, pulse oximeters, colposcopes, Dopplers, and vital sign monitoring equipment. All products are backed by a three-year manufacturer warranty with on-site customer service and factory-trained engineers guaranteeing 24-48 hour service turnaround. The company offers pricing 30-40% below major U.S. competitors while maintaining comprehensive support through a dedicated service center, learning resources, and EMR connectivity assistance.