Cutera has gained expanded indications from the U.S. Food and Drug Administration (FDA) for its truFlex muscle stimulation technology. The expanded clearance adds rehabilitative and therapeutic applications to its aesthetic use, and opens new treatment areas for the arms and calves.

The new indications include:

• Strengthening, toning, and firming of arms and calves
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
• Adjunctive therapy for the treatment of medical diseases and conditions (to be used under medical supervision)

“The new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength,” said Dr. Edward Alvarez, CEO and Founder of Restimulate Health. “Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey. I’m energized by what this means for my patients and the meaningful impact it will have in my practice.”

truFlex was introduced in 2019 and is powered by the company’s proprietary Multi-Directional Stimulation (MDS) technology to induce controlled muscle contractions in targeted muscle groups by delivering energy through applicators that can be customized to a patient’s body shape or targeted treatment area.

“Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today. These new clearances mark an important milestone in Cutera’s mission to improve the lives of patients through advanced, versatile solutions that address both aesthetic and therapeutic demand,” said Taylor Harris, CEO of Cutera. “By extending truFlex’s uses into rehabilitation and recovery, we are opening new opportunities for providers to support patients across a broader spectrum of care.”