Assessment tools company King-Devick technologies inc reported on Tuesday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) to market its new K-D Balance application to objectively measure a patient's balance in May 2018.
According to the company, K-D Balance uses secure, HIPAA-compliant cloud-based technology offering healthcare providers secure patient management. K-D Balance utilises an iPhone or iPod Touch and aids in assessing balance in individuals with conditions which could affect balance, including concussions, orthopedic injury, vestibular dysfunction, headaches, aging, Parkinson's, multiple sclerosis, medication side effects as well as fatigue.
In conjunction, research has shown the single-leg stance to be highly variable even in healthy patients, resulting in unreliable and time-consuming evaluations. The company's K-D Balance assesses three key balance stance metrics: double stance, right tandem stance and left tandem stance.
Concurrently, the Mayo Clinic Sideline Concussion Screening Protocol utilises the King-Devick Test in association with Mayo Clinic as an integral part of its sideline protocol along with tests of dynamic balance and cognition.
Amaal Starling, MD, neurologist at Mayo Clinic, co-authored a peer-reviewed article published in Concussion Journal in which she raises concerns about the single-leg stance utility in the evaluation of concussion based on the study results, concluded the company.
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