Zynex Inc (NASDAQ:ZYXI) announced that its portable pain management device TensWave has achieved Food and Drug Administration (FDA) clearance.
The prescription-only TensWave device aims to provide pain relief through TENS (Transcutaneous Electrical Nerve Stimulation) therapy, which the company highlighted has been clinically proven to reduce chronic and acute pain without needing medication.
"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," Zynex CEO Thomas Sandgaard said in a statement.
Zynex noted that the TensWave device is not intended to replace its NexWave electrotherapy device, which remains its top choice for patients seeking a comprehensive electrotherapy solution.
TensWave is a complementary therapy designed for patients whose insurance plans only cover TENS therapy.
"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,” Sandgaard said.
“It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients.”
Zynex shares moved higher on the update, adding 2% at US$8 late morning on Tuesday.