Special 510(k) Filing Nets Signifier Medical Removal of a Contraindication

After filing a Special 510(k) requesting a change to its existing device clearance, Signifier Medical Technologies received FDA’s approval to remove a contraindication for its eXciteOSA daytime therapy for obstructive sleep apnea (OSA).

The OSA therapy was contraindicated for patients with intraoral metal dental work, such as temporary or permanent implants, braces, and prostheses, restorations, and appliances.

Signifier provided real world evidence (RWE) to the agency from a dental study by canvassing 499 of its existing patient population, the company told FDAnews. The study found that there was no significant difference in side effects amongst those with and without intraoral metal dental work.

The OSA therapy uses neuromuscular electrical stimulation to “exercise” the upper airway muscles to improve endurance and prevent airway collapse during sleep.