Voxello Receives FDA 510(k) Clearance for the Noddle™ Speech Generation Device

Voxello, developer of communication solutions for impaired hospitalized patients, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the noddleTM, a pioneering solution that detects voluntary gestures in hospitalized patients who would otherwise be unable to communicate.

“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.”

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.”

In addition, the Company has closed a Series A round of financing. Rick Vaughn, Managing Director of Mid-America Angels said, “Effective communication between patient and provider is critical to the delivery of safe, high-quality healthcare. Voxello is leading the way in assisting severely impaired patients to express their needs and wishes to caregivers. Mid-America Angels is excited to be coming aboard as an engaged partner.”

About Voxello

Voxello provides solutions for impaired hospitalized patients who cannot communicate by traditional means. The company’s first product, the noddleTM, detects voluntary gestures such as clicking sounds made with the tongue or an eye blink to control nurse call and speech generation devices. For more information about Voxello, please visit www.voxello.com.

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