In prospective, randomized, double-blind, placebo-controlled, multi-center clinical studies, pulsed, low-intensity ultrasound has been proven to be effective in decreasing the time to heal in both fresh diaphyseal (tibia) and metaphyseal (distal radius) fractures. It also decreases the likelihood of a delayed union (>150 days to heal) in tibia fractures and loss of reduction in distal radius fractures. World-wide clinical studies, using pulsed, low-intensity ultrasound for treatment of non-union in a self-paired control study design, have demonstrated a heal rate of 88% with an average treatment time of 4.5 months in non-unions and an average fracture age of 23 months. The therapy is safe and non-invasive, and is used by the patient at home for a 20-minute treatment session per day.