June 29, 2020
Boston Scientific receives FDA clearance for heart monitoring system
Photo | TMS Aerial Solutions
Boston Scientific's Marlborough headquarters
Marlborough medical device manufacturer Boston Scientific has received U.S. Food and Drug Administration clearance for its LUX-Dx Insertable Cardiac Monitor System, the company announced on Monday.
The system is a long-term diagnostic device, which is implanted in patients and used to detect arrhythmias associated with conditions like atrial fibrillation, cryptogenic stroke and syncope.
The device detects and verifies potential arrhythmias and sends an alert to clinicians who can then make further determinations. The system allows doctors to adjust detection settings remotely, without requiring in-person visits.
A limited market release will begin immediately, with a full launch scheduled for later in the year.
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