Bioventus says FDA reclassified Exogen bone stimulator; 2026 guidance reiterated
Bioventus disclosed that the FDA issued a final order on April 16, 2026 reclassifying non-invasive bone growth stimulators, including its Exogen Ultrasound Bone Healing System, from Class III to Class II devices. CMS also updated billing requirements and the Medicare fee schedule for these devices for dates of service on or after May 18, 2026, and the company reiterated its 2026 financial guidance, though it said further CMS changes could require a revised outlook.
Key points
- FDA final order dated April 16, 2026 reclassified bone growth stimulators from Class III to Class II
- CMS updated billing requirements and Medicare fee schedule under HCPCS codes E0747, E0748, and E0760 for dates of service on or after May 18, 2026
- Bioventus does not presently expect reimbursement rate changes to have a material impact on 2026 results and reiterated its 2026 guidance
- Future CMS changes to Exogen Medicare reimbursement rates could require a revised financial outlook
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on May 21, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.