Wound VOX™ Receives FDA Clearance for Combined Therapy
News related to:Bechtel Medical, Inc · 1 min read
PHOENIXVILLE, Pa., Nov. 10, 2026 /CourierPR/ -- Bechtel Medical, a medical device company based in Phoenixville, Pennsylvania, has announced that its flagship product, Wound VOX™, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks the first 510(k)-cleared combined negative pressure and topical oxygen system, integrating two therapeutic capabilities into a single platform. Wound VOX™ incorporates three modes of operation: continuous negative pressure wound therapy (NPWT), intermittent NPWT, and intermittent NPWT with adjunctive topical oxygen therapy (TOT).
Negative Pressure Wound Therapy (NPWT) has been widely studied and used in the marketplace for decades, often referred to as a "Gold Standard" therapy for a variety of complex wounds. Topical Oxygen Therapy (TOT) has also gained attention in the treatment of complex wounds but continues to face reimbursement challenges. Wound VOX™ integrates these two therapeutic technologies into a single platform, aiming to simplify the delivery of advanced wound care while addressing some of the operational and economic barriers that have historically limited access to these therapies.
Independent clinical research has examined the potential benefits of combining NPWT and topical oxygen therapy. In a 2025 systematic review and meta-analysis published in Advances in Wound Care, Su et al. evaluated 11 randomized controlled trials and reported significantly higher complete wound healing rates and lower rates of bacterial positivity with combination treatment compared to NPWT alone. These findings concern the treatment approaches studied and were not generated from clinical studies of Wound VOX™.
Bechtel Medical plans to launch a limited commercial release of Wound VOX™ in December 2026.
Wound VOX™ is part of Bechtel Medical's product portfolio, which is grounded in engineering excellence, clinical insight, and a commitment to patient safety. The company's portfolio reflects a focus on responsible innovation, addressing unmet clinical needs while maintaining rigorous standards of quality and compliance.