Bioelectronic device company Tivic Health has secured CE mark approval for its ClearUP sinus pain relief device.

ClearUP, which delivers a microcurrent waveform, has been approved for temporary relief of sinus pain, pressure and congestion.

ClearUP is a small handheld device that enables to eliminate chemical side effects

ClearUP is a small handheld and drug-free device without any chemical side effects. It will be provided as over-the-counter without a prescription to support more than 50 million allergy sufferers in the US to manage their sinus pain.

Part of new non-invasive neuromodulation devices, ClearUP is said to serve as a safe and non-drug option for patients with a variety of medical conditions.

In January 2019, Tivic Health secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ClearUP sinus pain relief device.

The device is provided with an advanced technology to measure the user’s exclusive skin properties to target the optimal treatment points.

According to the company, the FDA clearance and CE mark approval allow to market the ClearUP device in more than 190 countries across the world.

Tivic Health CEO Jennifer Ernst said: “With the worldwide growth in sinus and allergy diseases, we look forward to forming strong partnerships to launch ClearUP internationally. For decades, the medical community has focused on treating conditions almost exclusively with chemical and drug therapies.

“We now see a growing number of companies exploring bioelectronic medicine – replacing drugs with targeted electrical stimulation. I am excited to be delivering one of the first non-prescription bioelectronic solutions to mainstream markets.”

Established in 2016, Tivic Health is involved in the development of microcurrent therapy solutions for the treatment of chronic diseases and conditions.