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Tenex Health Announces 510(k) US FDA Clearance for TX®-Bone to Help Patients Restore Musculoskeletal

Posted: Thursday, June 13, 2019

 

Lake-Forest based Tenex Health, Inc. received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize TX-Bone. TX-Bone is a new healthcare technology designed to simply remove pain-causing bone and calcific tissue to improve musculoskeletal function. This technology allows healthcare professionals to optimize ultrasonic energy through selective cutting and debriding of pain-generating bone and tissue. Applications include rotator cuff, triceps, the gluteus/trochanteric region, Achilles tendon insertion, Haglund’s deformity, and plantar fascia insertion spurs. 

“FDA clearance for Tenex Health’s new product, TX-Bone, represents a major advancement in the management of patients with tendinopathy, including those who suffer from bony spurs,” said Bernard Morrey, MD of the Mayo Clinic in Rochester, MN. “TX-Bone is extremely efficient for treating soft tissue, but also very effective at removing pain-causing bone and calcific tissue. The data that we have obtained suggests that these additional capabilities have the same benefits and safety of Tenex Health’s other minimally invasive technologies.” 

Tenex Health, Inc. is a privately held medical technology company, located at 26902 Vista Terrace, Lake Forest, CA 92630. Tenex Health Inc. is dedicated to delivering healthier and more pain-free lifestyles for active patients by providing healthcare professionals with innovative and minimally invasive technology that eliminates chronic tendon pain.

For more information, please visit http://www.tenexhealth.com.

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