Voxello Receives FDA Clearance for Noddle Speech-Generation Device
Voxello, a developer of communication solutions for impaired hospitalized patients, today announced the U.S. Food and Drug Administration has given it 510(k) clearance of the noddle, a device that detects voluntary gestures in hospitalized patients and turns them into spoken words.
"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," said Rives Bird, CEO of Voxello, in a statement. "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 allows patients who cannot communicate traditionally due to limited motor capabilities to control up to three devices with a single touch. With just a tongue click, for example, 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.
"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," said Mathew Howard, chair and DEO, Department of Neurology, University of Iowa Healthcare System, one of the healthcare providers involved in clinical trials of the noddle.
In addition, Voxello has closed a Series A round of financing led by Mid-America Angels.
"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," said Rick Vaughn, managing director of Mid-America Angels, in a statement.