Uromedica submits male incontinence device data to FDA

Uromedica has submitted its male incontinence device data to the US Food and Drug Administration (FDA).

Uromedica has sent the data, which included a clinical analysis of more than 120 men and is expecting the agency’s decision with in a few days, medcitynews reports.

Uromedica CEO Tim Cook said if the FDA accepts the data, they would go ahead with a premarket approval (PMA) application for its male device, which would likely be completed in the second half of the year.

The company concluded that it would also resubmit its female incontinence treatment and will raise additional private capital to complete new studies.