FDA clears next-generation insertable device for long-term arrhythmia monitoring
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Key takeaways:
- Boston Scientific announced the FDA clearance of its next-generation insertable cardiac monitor for long-term arrhythmia monitoring.
- The device can be programmed remotely without in-person visits.
Boston Scientific announced the FDA clearance and launch of its next-generation insertable cardiac monitor for long-term monitoring of arrhythmias associated with atrial fibrillation, cryptogenic stroke and syncope.
The system (LUX-Dx II+) is designed with algorithms to detect and verify arrhythmias before sending an alert to clinicians and allows patient care teams to adjust event detection settings remotely and record symptoms without in-person visits, according to a company email sent to Healio.
In addition, the system includes further levels of verification filters, including options for nighttime programming specific to bradycardia and pause episodes developed to reject false positives and irrelevant episodes, according to the email.
“The LUX-Dx II+ ICM System builds on a strong foundation of cardiac diagnostic technologies at Boston Scientific to provide care teams with the necessary data for critical decision making,” Scott Olson, senior vice president and president of cardiac rhythm management and diagnostics at Boston Scientific, said in the email. “With enhanced and new diagnostic algorithms, physicians will receive timely, accurate and actionable insights to help them make clinically meaningful decisions.”
As Healio previously reported, the first generation of this device (LUX-Dx) was cleared by the FDA in June 2020.
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