Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to communicate through voluntary gestures. Voxello touts the noddle as allowing patient access to nurse call systems, environmental controls, communication apps, and speech generating devices with a touch or a click of the tongue.

Coralville, Iowa-based Voxello was founded in 2013 through the Iowa Medical Innovations Group (IMIG) at the University of Iowa. IMIG is an interdisciplinary program that includes students from the Colleges of Medicine, Business, Law, and Engineering. The noddle student team consisted of Vince Hahn, Zihan Zhu, Blake Martinson, and Ben Berkowitz, with Richard Hurtig serving as professor mentor.

Commenting on the 510(k) clearance, Voxello CEO Rives Bird said:

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.

The following video is provided on Voxello’s website:

Matthew A. Howard, Chair and DEO, Dept. of Neurology, University of Iowa Healthcare System, commented on his experience with the device:

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.

Additionally, Voxello recently closed a Series A round of financing: on February 20, 2017, the Kansas City-based Mid-America Angels investment group announced that it invested $287,000 into Voxello.