This article was originally published in The Gray Sheet
American Medical Electronics gains FDA approval of a premarket approval supplement to reduce Spinal-Stim treatment time from eight to two hours. AME says that it has just begun a "guarantee" program for patients using the bone stimulator as an adjunct to lumbar fusion surgery; patients who comply with use guidelines but are diagnosed as having a radiographic fusion failure will be fully reimbursed for Spinal-Stim rental fees. "The combination of the significantly lower daily treatment time and money-back guarantee provides a much stronger argument for surgeons to prescribe Spinal-Stim units to help increase the potential heal rate for their patients," the company says.
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