CUTERA, a leading provider in aesthetic, dermatological solutions, announced that the U.S. Food and Drug Administration (FDA) has granted expanded indications for its truFlex muscle stimulation technology. This expanded clearance moves truFlex beyond aesthetic use alone, adding rehabilitative and therapeutic applications and opening new treatment areas for the arms and calves.
“The new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength. 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,” said Dr. Edward Alvarez, CEO and Founder of Restimulate Health.
The newly expanded 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)
“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.”
truFlex was introduced to the market in 2019 and is powered by 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. With this clearance, Cutera can now partner with physicians, rehabilitation specialists, and other providers to deliver expanded benefits that support both patient wellness and clinical outcomes.
