Bioventus Says FDA Reclassifies Exogen Ultrasound Bone Healing System To Class II Device On April 16, 2026; CMS Updates Medicare Fee Schedule For Non-Invasive Bone Growth Stimulators Effective May 18, 2026; Does Not Expect Material Impact From Exogen Reimbursement Changes In FY26; Reiterates 2026 Financial Guidance - SEC Filing
On April 16, 2026, the U.S. Food and Drug Administration ("FDA") issued a final order reclassifying non-invasive bone growth stimulators, including the Company's Exogen® Ultrasound Bone Healing System, from Class