Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System

Boston Scientific Given FDA 510(k) Clearance for Insertable Cardiac Monitor System
This cardiac monitor allows physicians to monitor patient data without the need for face-to-face appointments.

Boston Scientific has been granted FDA 510(k) clearance for their LUX-Dx insertable cardiac monitor system. This long-term diagnostic device is used to detect arrhythmias from conditions such as atrial fibrillation, syncope, and cryptogenic stroke.

The LUX-Dx’s multi-stage algorithm first detects potential arrhythmias, then verifies them. When an arrhythmia is verified, clinicians are immediately alerted, so that they can begin planning the necessary action.

This device can also be programmed remotely by clinicians, allowing the device’s event detection settings to be changed without a clinician present, a feature that is not found in any other insertable cardiac monitors. This is beneficial to patients, as they can remain in their own home. The feature also joins a host of telemedicine technologies developed recently in an effort to keep both clinicians and patients safer from possible COVID-19 infection.

The LUX-Dx can be programmed to identify several arrhythmias, including atrial flutter, bradycardia and tachycardia episodes, and rhythm pause. Clinicians set thresholds or parameters of arrhythmia, and the device then detects whenever these are exceeded. The verification filters then come into effect, preventing potential false negatives and unnecessary alerts to clinicians.

A mobile device accompanies the LUX-Dx to store its data, which connects to the cardiac monitor through Bluetooth. Data can be sent to the LATITUDE Clarity Data Management System daily, or as needed. A full launch of this product is commencing later in 2020.

Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific said:

“For physicians, receiving accurate monitoring data and having remote access to programming provides the opportunity to operate with more efficiency and confidence. The LUX-Dx ICM System is designed to provide physicians the ability to accelerate critical clinical decisions and allow them to spend more time focusing on patient outcomes by reviewing monitoring data and catching false positive detections without compromising sensitivity.”

Via: Boston Scientific

For Further Information

This recent development presents interesting implications for the future of the cardiology market. iData Research’s Cardiac Rhythm Management Market Analysis, Size, Trends | Global | 2019-2025 | MedSuite contains a detailed international market analysis, including in-depth interviews and procedural volumes.