eMotus Respiratory Motion Management System
EmpNia Inc.The eMotus Respiratory Motion Management System by EmpNia Inc. helps monitor and record patients' breathing patterns to improve the accuracy of CT diagnostic imaging and radiation therapy. By tracking respiratory motion, it aids clinicians in synchronizing image acquisition and radiation delivery, reducing motion-related artifacts and improving treatment precision. The device uses optical fiber sensors attached to the patient's chest or abdomen to generate a respiratory waveform and gate signals that help coordinate imaging and therapy devices.
Intended Use
The EmpNia eMotus system is used to measure and record the patient's respiratory waveform to aid with respiratory-synchronized image acquisition or reconstruction during CT diagnostic imaging or radiation treatment planning procedures, where there is a risk of respiratory motion compromising the resulting image. It is also used to derive and communicate a Gate signal to aid with organ position verification and radiation therapy treatment accuracy during CT or X-ray imaging.
Technology
The system includes a disposable adhesive optical fiber sensor pad placed on the patient's thorax or abdomen, connected to optical fiber cables and a transceiver that digitizes respiratory motion data. This data is processed by proprietary software on a computer, producing respiratory waveforms and gating signals that can interface with external diagnostic imaging or radiation therapy devices. It supports threshold and phase gating to control radiation delivery or synchronize image acquisition.
Performance
The device underwent biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, cybersecurity, human factors, and extensive bench performance testing. Bench tests confirmed equivalent respiratory waveform outputs compared to a predicate device, stable performance across conditions, and meeting latency requirements, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/19/2024
6 months - 2
FDA Approval
6/27/2025
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