FDA 510(k) for Noddle speech generation device

Coralville, Iowa – Officials from Voxello, developer of communication solutions for impaired hospitalized patients, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Noddle.

“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 $3 billion in preventable adverse events. The FDA clearance of the Noddle brings us one step closer to offering a solution for this urgent, unmet need,” says Rives Bird, CEO of Voxello.

Voxello’s submission was reviewed and cleared by the FDA in 78 days while a typical clearance can take up to 120 days.

“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,” says Bird.

The Noddle provides patients who cannot communicate traditionally and who may have limited motor capabilities the ability to control up to three different devices with a single touch. With just a tongue click a patient can call a nurse and communicate with a speech generating device. Phase I and II clinical trials were conducted and confirmed that the Noddle positively impacted patient satisfaction with statistical significance.

Mathew A. Howard, Chair and DEO, Department of Neurology, University of Iowa Healthcare System commented on his experience during clinical trials, “The technology incorporated in the Voxello Noddle has been extremely helpful in enabling us to provide the best possible care for neurosurgery patients with severe neurological injuries.”

Source: Voxello