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FDA reclassifies Bioventus Exogen bone stimulator, CMS updates Medicare billing rules
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FDA reclassifies Bioventus Exogen bone stimulator, CMS updates Medicare billing rules
  • FDA issued a final order on April 16, 2026 reclassifying non-invasive bone growth stimulators, including Exogen, from Class III to Class II devices.
  • CMS updated billing requirements and the Medicare fee schedule for non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748, and E0760 for dates of service on or after May 18, 2026.
  • Based on current information, no material impact is expected on fiscal 2026 results, leaving 2026 guidance unchanged.
  • Longer-term reimbursement risk remains if CMS makes further changes to Medicare rates for Exogen, which could force a revision to the company’s outlook.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bioventus Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001665988-26-000029), on May 21, 2026, and is solely responsible for the information contained therein.

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