Koya Medical Receives FDA Clearance for Dayspring Lite

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Koya is a Rosenman Innovator company. From Venous News

Koya Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its Dayspring Lite treatment for lymphoedema and venous disease. Unlike traditional compression pumps that require patients to be tethered to the wall during use, the Dayspring family of treatments enables people to enjoy movement and mobility during their active compression therapy.

Dayspring Lite is a prescription-only treatment for people who need to add basic active compression to their lymphoedema regimen. It uses the same Flexframe technology and smart, rechargeable, hand-held controller available in the Dayspring flagship product. While Dayspring Lite is non-calibrated and provides fewer customisation options than the flagship treatment, the product is designed to meet the needs of those who require more essential compression therapy to clear lymph fluid.

With Dayspring Lite, patients can select and monitor from the Koya app one of three standard treatment intensities. If the patient’s needs evolve to require calibration and additional customisation, Koya Medical can support a seamless transition to the more advanced Dayspring therapy.

“Managing chronic diseases like lymphoedema, which often occurs as a result of cancer or cancer treatment, is a journey and we know that needs can evolve throughout that journey,” said Andy Doraiswamy, founder, president and CEO of Koya Medical. “We are committed to developing treatment options that support patients as they manage all phases of this chronic condition so they can get back to the active, productive lives they enjoy.”

The Dayspring system 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 programme custom treatment options. Koya previously received FDA 510(k) clearance for the Dayspring flagship product for both upper and lower extremity lymphoedema. Koya Medical is committed to providing patients and caregivers a complete suite of solutions that provide coordinated and comprehensive care of this chronic condition.