FDA clears transcutaneous electrical nerve stimulation device for chronic pain

The FDA has granted clearance to a Colorado-based medical technology company’s transcutaneous electrical nerve stimulation device for those suffering from chronic pain, according to a press release.

The noninvasive, portable, prescription-only TensWave device is designed to relieve acute pain without medication, Zynex Inc. stated in the release. It is intended to be used as a complementary product for patients whose insurance plans do not cover the company’s “market-leading NexWave electrotherapy device,” which Zynex said “remains the top choice for patients seeking a comprehensive electrotherapy solution.”

“The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions,” Zynex Medical CEO Thomas Sandgaard said in the release. “We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand.”