Voxello, the producer of the noddle, a medical device that helps impaired patients communicate with nurses and caregivers, has received FDA clearance for the trademarked device, and recently closed a Series A funding round of more than $800,000.
“At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent, unmet need,” said Rives Bird, CEO of Voxello.
The company undertook the rigorous FDA clearance process and was able to complete its submission in October, 2016. A typical clearance can take up to 120 days. Voxello’s submission was reviewed and cleared by the FDA in 78 days.
Bird continued, “Our team worked diligently to develop a thorough submission allowing us to bring the noddle to market as quickly as possible. I’m pleased not only with the results of our team, but the process and timely clearance of this product.”