Boston Scientific receives FDA 510(k) clearance for cardiac diagnostic device

Boston Scientific has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System.

The new, long-term diagnostic device is implanted in patients to detect arrhythmias associated with conditions such as Atrial Fibrillation (AF), cryptogenic stroke and syncope.

The system is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before sending an alert to clinicians. The device is also fitted with remote programming capabilities via the Latitude Clarity Data Management System website, allowing physicians and care teams to adjust event detection settings without requiring an in-person patient appointment. This feature is advantageous as it is not thought to be available on any other ICM currently on the market.

Kenneth Stein, senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific, commented: "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."

Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific, added: "The LUX-Dx ICM System represents a significant step forward in developing the diagnostic portfolio for Boston Scientific.

"The addition of this new offering, alongside existing products and services, affirms our commitment to providing meaningful innovations for the detection and treatment of patients with cardiac arrhythmias."

The company has announced an immediate limited market release of the LUX-Dx ICM System in the United States, with a full launch of the product planned to commence later this year.