NeurAxis, Inc. announced on December 10, 2024, that it received FDA 510(k) clearance for its Rectal Expulsion Device (RED). This device is designed for the testing and evaluation of patients with chronic constipation, specifically those with pelvic floor dysfunction.
The RED device is engineered to replicate the performance of traditional balloon expulsion tests and manual sensation testing devices without requiring electronics or software. This offers a streamlined and potentially more accessible diagnostic tool for physicians.
Crucially, the RED procedure already benefits from a Category I CPT code and has positive policy coverage by Medicare and most commercial insurance companies. NeurAxis plans to begin commercial marketing of RED and anticipates generating initial revenues from the device as early as the first quarter of 2025, leveraging existing reimbursement pathways.
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