Tivic Health’s Sinus Pain Relief Device Earns Expanded FDA Indication
Tivic Health has received an expanded FDA indication for its ClearUP Sinus Pain Relief device that clears the product to treat congestion caused by allergies, the flu and the common cold.
The small, handheld device previously received de novo approval for treating allergy-related sinus pain caused by seasonal and year-round allergies.
The noninvasive, medication-free device works by providing low-current electrical waves to the patient to relieve sinus and nasal congestion and allergy-related sinus pain. The device has already been cleared in Europe for the temporary relief of sinus pain, pressure and congestion.