MONARCH™ Platform (MON-000008)
Auris Health, Inc.The MONARCH™ Platform is a robotic bronchoscopy system that provides physicians with precise, image-guided navigation and visualization of patient airways. It integrates electromagnetic tracking with real-time video from a flexible bronchoscope and can optionally update navigation using live imaging from Cone Beam CT scans. This aids clinicians in diagnosing and treating lung conditions with improved accuracy and control.
Intended Use
The MONARCH™ Bronchoscope and the MONARCH™ Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Technology
The device is a robotic bronchoscopy system with four main components: cart, tower, bronchoscope, and controller. It includes an electromechanical system that enables precise control of a flexible bronchoscope with continuous video and electromagnetic navigation based on pre-op CT scans, optionally updated with Cone Beam CT imaging during procedures. Updated hardware and software allow integration with Cone Beam CT systems and include cybersecurity enhancements.
Performance
Non-clinical performance testing included hardware electrical testing, navigation location accuracy, software functional testing, safety and EMC testing, simulated use accuracy tests, and human factors pre-clinical cadaver tests. These confirmed device performance, safety, and effectiveness with no new safety or effectiveness concerns. Clinical data was not deemed necessary.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/7/2024
3 months - 2
FDA Approval
1/23/2025
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