Biomedical Systems receives 510(k) clearance from the FDA for TruVue™ Wireless Ambulatory ECG Monitoring System

Share Article

TruVue combines automatic wireless data transmission and sophisticated arrhythmia analysis to provide a comprehensive long-term ECG monitoring solution for patients with existing cardiac arrhythmia or those who may experience symptoms suggestive of abnormal rhythm patterns.

Biomedical Systems, a global leader in providing cardiologists, clinics, and hospitals with cardiac diagnostic services and products, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market TruVue™, a wireless ambulatory ECG monitoring system. TruVue is the industry's first cardiac Mobile Telemetry system that analyzes, records and transmits every heart beat for up to 30 days.

TruVue combines automatic wireless data transmission and sophisticated arrhythmia analysis to provide a comprehensive long-term ECG monitoring solution for patients with existing cardiac arrhythmia or those who may experience symptoms suggestive of abnormal rhythm patterns. The transmitted ECG is reviewed and validated by certified Cardiac technicians and symptomatic patient events or abnormal ECG findings are posted on-line immediately for physician review.

Jim Ott, President of the Cardiology Division, commented "We are pleased to have reached this milestone in the development of our newest product platform and look forward to launching the TruVue service. The name 'TruVue' is symbolic of the fact that our system will be the first wireless ambulatory ECG system in the market that records and transmits every beat during the monitoring period. Therefore, prescribing physicians will have the capability of viewing any portion of the ECG that occurs while the patient is being monitored."

Biomedical Systems has been a leading provider of Ambulatory ECG monitoring solutions for cardiologists, clinics, and hospitals with non-invasive cardiac diagnostic services since 1975. We also offer Holter Monitoring with Data Exchange for transfer, review, and management of cardiac data, Cardiac Event Monitoring with ReportWeb for immediate access to CEM reports, and the Century Series Holter Analysis System and Software™ System.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Kristy Galkowski
Biomedical Systems
800-877-6334 ext. 3918
Email >
Visit website