The FDA has expanded indications for Cutera’s truFlex device to include rehabilitative and therapeutic uses beyond aesthetic treatments.

The U.S. Food and Drug Administration has expanded the indications for truFlex, a muscle stimulation technology developed by Cutera, to include rehabilitative and therapeutic applications in addition to its original aesthetic use.

Expanded Treatment Areas and Uses

The new clearance allows truFlex to be used for treatment of the arms and calves. Approved therapeutic uses now include relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, and maintaining or increasing range of motion. It is also cleared for immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and for adjunctive therapy under medical supervision.

“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.

Market Impact and Company Statement

Cutera introduced truFlex in 2019. The system uses Multi-Directional Stimulation technology to deliver energy through customizable applicators designed to match patient body shapes and treatment areas.

“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.”

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