Reliable. Safe. Tested.

FDA 510(k) Cleared

The Frontier X Plus is designed with reliability, safety, and performance at its core, ensuring precise, high-quality cardiac monitoring. Its FDA clearance reinforces its safety standards, giving you confidence in its use for arrhythmia detection and remote monitoring applications. Built with secure data transmission and encryption, it ensures patient information remains protected at all times.

Get Frontier X Plus

The Frontier X Plus is designed with reliability, safety, and performance at its core, ensuring precise, high-quality cardiac monitoring. Its FDA clearance reinforces its safety standards, giving you confidence in its use for arrhythmia detection and remote monitoring applications. Built with secure data transmission and encryption, it ensures patient information remains protected at all times.

Technical Safety and Performance Testing

Frontier X Plus Device

  • IEC 60601-2-47:2014 Medical Electrical Equipment Part 2-47: Particular Requirements for the safety. Including essential performance of ambulatory electrocardiographic systems.
  • IEC 60601-1:2005, AMD1:2012 Medical Electrical equipment - Part 1:General requirements for basic safety and essential performance.
  • IEC 60601-1-2:2014 +AMD1: 2020 CSV, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances Requirements and tests.
  • IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Chest Strap

  • Compliant with REACH and RoHS2 standards.

Clinical Validation

This study aimed to validate the Frontier X Plus (FX+) single-lead, continuous ECG device by comparing its performance against the traditional FDA Cleared 12-lead ECG in ​832 patients​ in both a clinical and real world setting including individuals with and without atrial fibrillation (AFib). The performance of the Frontier X Plus in detecting atrial fibrillation (AF) demonstrated a sensitivity of 98.10% and a specificity of ​97.88%, when compared to the paired gold standard device as adjudicated by 3 independent cardiologists.

FAQ’s

What safety standards does the Frontier X Plus comply with?

The Frontier X Plus ECG monitor meets multiple international safety and performance standards, including IEC 60601-2-47:2014, IEC 60601-1:2005 (AMD1:2012), IEC 60601-1-2:2014 (AMD1:2020), and IEC 60601-1-11:2015. These certifications ensure compliance with medical electrical safety, essential performance, and electromagnetic disturbance requirements.

Is the Frontier X Plus safe for use in home healthcare settings?

Yes, the device complies with IEC 60601-1-11:2015, which outlines safety and performance requirements for medical electrical equipment used in home healthcare environments.

Does the device interfere with other electronic medical equipment?

No, the Frontier X Plus complies with IEC 60601-1-2:2014 + AMD1:2020, which sets standards for electromagnetic disturbances, ensuring it does not interfere with or get affected by other medical equipment.

Is the chest strap material safe for prolonged skin contact?

Yes, the chest strap complies with REACH and RoHS2 standards, meaning it is free from harmful substances and safe for extended wear.

What regulatory approvals does the Frontier X Plus have?

The ECG monitor is FDA 510(k) cleared, affirming its safety, effectiveness, and compliance with regulatory standards for medical devices.

Can the device be used for long-term ECG monitoring?

Yes, it is designed for ambulatory ECG monitoring, meeting IEC 60601-2-47:2014 standards, and ensuring reliable long-term data collection.

Does the device require professional assistance for application?

No, the Frontier X Plus is self-applied, requiring minimal staff intervention and making it easy for patients to use independently.

Can the device be used in both clinical and remote settings?

Yes, it is suitable for clinical, home healthcare, and ambulatory use, meeting multiple IEC safety and performance standards.

Does the device support continuous ECG monitoring?

Yes, the Frontier X Plus offers continuous data streaming, allowing clinicians to access ECG insights for faster diagnosis and intervention.

What makes the Frontier X Plus a reliable choice for ECG monitoring?

The device is safety-certified, clinically tested, and meets global regulatory standards, ensuring precise, secure, and high-quality cardiac monitoring in various healthcare environments.

Note:

The Frontier X Plus (FX+) is a prescription only US FDA 510(k) cleared medical device for ambulatory ECG monitoring. It is not tested for use in individuals with pacemakers or ICDs. It is not meant for the diagnosis of cardiac ischemia. Please request the IFU for intended use, indications, contraindications and availability in your geography.

Disclaimer: All images used are for illustrative purposes only.