Koya Medical has received Food and Drug Administration (FDA) 510(k) clearance for its Dayspring active compression therapy system to treat lymphedema and venous diseases that impact lymphatic flow in lower extremities, the company announces.
Koya previously received FDA clearance for Dayspring for upper extremities in June 2020, according to the company in a news release.
The Dayspring system is a wearable and mobility-enabled compression system designed to enable movement, mobility and personalized care. It includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary Flexframe technology; a smart, rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to program custom treatment options.
Lymphedema is a progressive, incurable condition where a buildup of protein-rich fluid causes painful swelling in the arm, leg and/or other regions of the body.
“Lymphedema can be physically and emotionally debilitating for patients, so a daily treatment option that enables mobility and allows them to receive treatment while continuing their daily life activities is a significant breakthrough.”
— Andy Doraiswamy, PhD, Koya founder, President and CEO
Koya is currently in a limited pilot launch of Dayspring for upper extremities, per the release.
[Source(s): Koya Medical, PR Newswire]