USFDAMay 21, 2026, 05:02 PM
Bioventus Exogen Device Reclassified by FDA; 2026 Guidance Reaffirmed
AI Summary
Bioventus Inc. announced that the FDA reclassified non-invasive bone growth stimulators, including its Exogen® Ultrasound Bone Healing System, from Class III to Class II devices. Following this, CMS updated billing requirements and the Medicare fee schedule for related HCPCS codes, effective May 18, 2026. The company currently does not expect these changes to materially impact its financial results for fiscal year 2026 and is reiterating its previously issued guidance. However, Bioventus will continue to evaluate potential long-term impacts of current and future CMS actions.
Key Highlights
- FDA reclassified non-invasive bone growth stimulators from Class III to Class II devices on April 16, 2026.
- Bioventus's Exogen Ultrasound Bone Healing System is included in the reclassification.
- CMS updated billing requirements and Medicare fee schedule for HCPCS codes E0747, E0748, E0760.
- New CMS billing requirements apply to services on or after May 18, 2026.
- Company does not expect a material impact on fiscal year 2026 financial results.
- Bioventus reiterated its previously issued financial guidance for 2026.
- Potential future CMS changes could require a revision of the financial outlook.
Price Impact
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