A medical device developed at the University of Iowa that assists impaired hospital patients communicate with health care providers recently received regulatory clearance from the U.S. Food and Drug Administration (FDA). The device, called the noddle, was developed by UI Communication Sciences and Disorders Professor Emeritus Richard Hurtig, now Chief Scientific Officer of the parent company Voxello.

“At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients,” said Rives Bird, Voxello CEO. “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 each year. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent unmet need.”

The noddle provides patients who cannot communicate traditionally and who may have limited motor capabilities the ability to call a nurse and communicate with a speech generating device operated by small movements like a tongue click, eye blink or hand movement.  

An early prototype of the noddle was conceived by a team of UI students participating in the Iowa Medical Innovation Group. Voxello signed an exclusive licensing agreement with the UI Research Foundation in 2015 for the technology, and received commercialization gap funding from the UI Office of Research and Economic Development’s UI Ventures program.

The company’s focused drive toward market launch saw them clear regulatory hurdles in record time. The rigorous FDA approval process typically takes up to 120 days. The noddle was reviewed and cleared by the FDA in 78 days.

Now with FDA clearance, Voxello will be able to expand its pool of clinical trials sites beyond the University of Iowa Hospitals and Clinics and into other high profile academic centers in the United States.

Voxello, which recently completed a Series A round of capital investment, is also hiring. Bird reported that at a recent job fair at the UI College of Engineering, student interest was high. The company is hiring three to four people immediately and is working to add a dozen new employees by the end of the 2018.

“Effective communication between patient and provider is critical to the delivery of safe, high-quality health care. Voxello is leading the way in assisting severely impaired patients to express their needs and wishes to caregivers,” said Rick Vaughn, managing director of Mid-America Angels, a Kansas-based private investment group who contributed to Voxello’s Series A round of financing. “Mid-America Angels is excited to be coming aboard as an engaged partner.”

For more information about Voxello, please visit www.voxello.com.

UI Ventures, part of the University of Iowa Office of the Vice President for Research and Economic Development, offers information and resources to help companies find funding they qualify for, including federal grants, state funding, the UI commercialization gap fund, loans, angel investment, and venture capital. For more information, visit http://uiventures.uiowa.edu/.

The Office of the Vice President for Research and Economic Development provides resources and support to researchers and scholars at the University of Iowa and to businesses across Iowa with the goal of forging new frontiers of discovery and innovation and promoting a culture of creativity that benefits the campus, the state, and the world. More at http://research.uiowa.edu, and on Twitter: @DaretoDiscover.