logo
Plus   Neg
Share
Email

Boston Scientific Gets FDA 510(k) Clearance For LUX-Dx Insertable Cardiac Monitor System

Boston Scientific Corp. (BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-DxInsertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

This is the first ICM device with remote programming paired with dual-stage arrhythmia detection algorithm. It then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making.

Further, the remote programming capabilities of the device via the LATITUDE Clarity Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market.

The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded.

The company will immediately begin a limited market release of the LUX-Dx ICM System in the U.S. with full launch of the product commencing later this year.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
European Medicines Agency or EMA announced that Comirnaty, the COVID-19 vaccine developed by Pfizer and BioNTech, can have more flexible storage conditions, including up to one month in a normal fridge. The proposed change in the approved storage conditions, recommended by EMA's human medicines committee or CHMP, will help in easy handling of the vaccine in vaccination centres across the EU. Kraft Heinz Foods Co. is recalling around 13,504 pounds of a frozen foodservice soup product citing misbranding and undeclared allergens, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The frozen soup product contains milk and eggs, known allergens, which are not declared on the product label. Walmart has dropped the requirement of masks for customers and members who are fully vaccinated against COVID-19 while they are at the store. This is based on the latest guidance issued by the Centers for Disease Control and Prevention late last week. The retail giant also announced a cash bonus for all fully vaccinated associates.
Follow RTT