Zynex noted that the TensWave device is expected to cater to patients who meet the specific criteria for insurance reimbursement for TENS therapy. Image credit: Kmpzzz / Shutterstock.

Zynex Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its electrotherapy device, TensWave.

The second electrotherapy device in Zynex’s portfolio, the TensWave device is cleared for pain management and rehabilitation through transcutaneous electrical nerve stimulation (TENS).

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The US-based company was quick to note that the newer device is not intended to replace its NexWave electrotherapy device, but would provide an alternative to patients whose “insurance plans exclusively 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,” said Zynex CEO Thomas Sandgaard.

“It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions.”

The global market for neuromodulation devices was worth approximately $6.06bn in 2023 and is expected to exceed $8.9bn in 2027, as per GlobalData market analysis. Multiple companies are developing neuromodulation and TENS devices for pain management.

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Neuronoff is developing an implant Injectrode device for chronic pain management. The minimally invasive device has an external pulse generator that sends signals through the skin to tell the implanted electrode what electrical output is needed on the nerve. The device is designed to be “virtually invisible” from the outside, thereby giving a more “aesthetic result” and preserving patient privacy.

Boston Scientific has also reported positive one-year data for its WaveWriter Alpha Spinal Cord Stimulation (SCS) system. The SOLIS trial results showed that the SCS device can reduce pain in chronic pain patients by 50%, with 85% of patients who declared a drop in pain reported a greater ability to take part in daily activities.

In January 2024, Nalu Medical reported positive long-term data from the COMFORT trial of its peripheral nerve stimulation (PNS) device to treat chronic pain. After 12 months, 87% of subjects using the Nalu system achieved more than 50% pain relief, with a 73% average pain reduction. 

Despite their widespread use and development, some of the electrostimulation devices, specifically spinal cord stimulators (SCS), have recently made headlines in Australia due to high rates of adverse effects. Australia’s Therapeutic Goods Administration ended up removing 82 SCS devices from the market after a series of reviews and a report from a national broadcaster claiming that the devices are neither safe nor effective.