1-channel ECG event recorder LUX-Dx™

wireless

Overview
The LUX-Dx™ Insertable Cardiac Monitor (ICM) System provides continuous subcutaneous ECG (S‑ECG) monitoring using a two‑electrode, leadless design. The system is engineered to emulate Lead II morphology and deliver clear S‑ECG signals for clinical review. A dual‑stage algorithm detects and verifies events before transmission to reduce false positives and limit unnecessary clinic workload. Remote programming enables non‑invasive device adjustments.

How it works
The LUX-Dx system applies a dual‑stage detection-and-verification algorithm to classify arrhythmic events prior to data transmission, improving diagnostic relevance. It continuously monitors atrial fibrillation (AF), atrial tachycardia (AT), pauses, tachycardia and bradycardia events, and includes false‑positive rejection logic. Remote programming allows clinicians to update detection parameters and therapy settings without an in‑person visit.

System components

• ICM device: compact, leadless implant placed subcutaneously in the left pectoral region; two electrodes capture S‑ECG data.
• LATITUDE Clarity™ Data Management System: clinic platform optimized for LUX-Dx to streamline data review and apply remote programming.
• Clinic and patient apps: LUX-Dx Clinic Assistant app and myLUX Patient app for device interrogation, status monitoring and patient engagement.

ICM device details
The LUX-Dx ICM is implanted subcutaneously in the left pectoral area and uses two electrodes to sense S‑ECG. Arrhythmia detection follows the programmed Reason for Monitoring or clinician‑set parameters. The device is MR‑conditional.

LATITUDE Clarity Data Management System
LATITUDE Clarity is designed specifically for LUX-Dx to help clinics prioritize events, streamline workflow, review data efficiently and deliver programming changes remotely, reducing unnecessary patient visits.

Clinic and patient apps
The LUX-Dx Clinic Assistant app and the myLUX Patient app support device interrogation, status checks and data transmission.

• Clinic Assistant app: connects to LUX-Dx devices within ~2 meters; displays device status and real‑time S‑ECG; enables interrogation and application of LATITUDE Clarity programming.
• myLUX Patient app: activates the implant, transmits data to LATITUDE servers, shows monitoring and connection status, provides reconnection guidance, supports one‑way messages from LATITUDE Clarity, and includes a symptom tracker and patient education.

Product literature and documents available on the site
Downloadable documents include Patient Quick Start Guide, User Manual, Product Brochure and Spec Sheet.

Specifications

• Volume: 1.2 cm3
• Mass: 3 g
• Dimensions (W × H × D): 7.2 mm × 44.8 mm × 4.0 mm
• Surface area of can electrode: 75.3 mm2
• Surface area of header electrode: 10.2 mm2
• Battery longevity: 3 years* (projected under specified usage scenarios)
• Monitored events: AF, AT, pause, tachycardia and bradycardia
• Implant location: subcutaneous, left pectoral region
• Electrodes: two electrodes for S‑ECG sensing
• MR‑conditional: yes
• Included system elements: ICM device, LATITUDE Clarity Data Management System, Clinic Assistant and myLUX Patient apps
• Ordering references (examples shown on page): LUX-Dx Insertable Cardiac Monitor — Model number M301; myLUX Patient Kit with Mobile Device — 6259; LUX-Dx Clinic Assistant Kit with Mobile Device — 6256; Magnet accessory — 6386

Notes regarding battery longevity: *3 years projected under the following usage scenarios: average of 1 auto‑detected event per day; average of 1 patient‑initiated event per month; ≤ 6 months shelf life between manufacture and insertion. At maximum shelf storage time of 18 months, longevity is reduced by ~4 months. Projected longevity is 2 years when Bluetooth Manual Connection is configured to not require a magnet.