Xstim, Inc. Receives FDA Approval for Xstim™ Spine Fusion Stimulator.

IRVING, Texas, April 16, 2024 /PRNewswire/ -- Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstim™ Spine Fusion Stimulator

Engineered with patient comfort and convenience in mind, the Xstim™ Spine Fusion Stimulator represents a significant milestone in the company’s product lineup of bone growth stimulators. This capacitively coupled device emits a low-energy signal clinically proven to promote bone healing after spinal fusion surgery1. Commercial availability of the Xstim device is slated for the second quarter of this year, with a targeted and phased launch plan in place to ensure widespread accessibility.

Xstim, Inc., announces its recent PMA approval from the FDA for Xstim™ Spine Fusion Stimulator.
The Xstim device has been meticulously designed to prioritize patient ease of use and wearability, offering a noninvasive alternative for indicated cases. With its intuitive interface and sleek design, featuring a large onboard color display, the Xstim device streamlines patient therapy management.

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