Boston Scientific Receives the US FDA’s 510(k) Clearance for its LUX-Dx Insertable Cardiac Monitor System

 Boston Scientific Receives the US FDA’s 510(k) Clearance for its LUX-Dx Insertable Cardiac Monitor System

Boston Scientific Receives the US FDA’s 510(k) Clearance for its LUX-Dx Insertable Cardiac Monitor System

Shots:

  • LUX-DxICM System is a dual-stage algorithm diagnostic device implanted in patients to identify AF, atrial flutter, rhythm pause, bradycardia, and tachycardia episodes and detect arrhythmias when established thresholds or parameters are exceeded
  • The dual-stage algorithm verifies arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Additionally, after implant, patients are provided with a mobile device preloaded with the MyLUX app which connects via Bluetooth to their ICM device
  • The app transmits device data daily/ as needed, to the LATITUDE Clarity Data Management System website providing remote programming capabilities to the device that enables physicians to adjust event detection settings without an in-person patient appointment

Click here to read full press release/ article | Ref: Boston Scientific | Image: The Boston Globe

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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