CORALVILLE, Iowa--Voxello, developer of communication solutions for impaired hospitalized patients, announced today that it has achieved several major milestones. The Company has filed a 510(k) pre-market notification with the U.S. Food and Drug Administration (FDA) for its first product, the noddle™. Voxello has also received notification from the US Patent and Trademark Office of allowance of 25 claims and anticipates a patent to be issued in the coming months.
In addition, the Company has received ETL certification for safety and electrical testing. The ETL Mark is proof of product compliance to North American safety standards, and is widely accepted as proof of product compliance to published industry standards.
Voxello provides solutions for impaired hospitalized patients who cannot communicate by traditional means. The noddle™, allows patients that may be immobile and cannot speak to access nurse call and speech generation devices through subtle movements like a tongue click, hand movement or eye blink.
“We are pleased that we have accomplished these critically important advancements,” said Rives Bird, CEO of Voxello. “These achievements bring us closer to our ultimate goal of impacting the lives of impaired hospitalized patients and their families through our innovative solutions.”
In 2012, The Joint Commission–the accreditation and certification body for the health care industry–mandated that care facilities provide appropriate communication avenues for patients who can’t verbally communicate. The noddle provides the healthcare community with the technological means for facilities to comply with this dictate.
“These patients struggle to try to communicate their needs and this is frustrating for both the patient and nursing staff. A device that allows patients to access the outside world to get help and communicate is invaluable for the patient, their family and staff. The noddle provides an easy way to communicate and it reduces possible misinterpretations,” said Jolyn Schneider, BSN, RN, PCCN, Nurse Manager, Department of Nursing Intensive & Specialty Services, University of Iowa Hospitals & Clinics, Burn Treatment Center.
Combined these developments allow Voxello to continue to drive the Company forward, and bring its pioneering technology to the healthcare community and impaired patients alike.
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.