FDA Clears SoftWave’s Wound-Treatment Device for Second-Degree Burns

SoftWave Tissue Regeneration Technologies has received an additional 510(k) clearance from the FDA for its OrthoGold 100 device for the treatment of second-degree burns in adults.

The device delivers an unfocused extracorporeal shockwave to promote a physical and biological response in the patient that improves burn-wound healing. The improved healing allows patients to recover faster from their injury and reduces the time they spend in physical and psychological pain.

OrthoGold 100 was previously cleared by the FDA for treating diabetic foot ulcers.