FDA Clearance for Mobile Lymphedema Treatment Device

OAKLAND, Calif. (September 30, 2021)–Koya Medical, a health care company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Dayspring Lite treatment for lymphedema 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—movement that is important to both quality of life and clinical outcomes.

Dayspring Lite is a prescription-only treatment for people who need to add basic active compression to their lymphedema regimen. It uses the same innovative Flexframe technology and smart, rechargeable, hand-held controller available in the Dayspring flagship product. While Dayspring Lite is non-calibrated and provides less customization 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 customization, Koya Medical can support a seamless transition to the more advanced Dayspring therapy.

“Managing chronic diseases like lymphedema, 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, Ph.D., Founder, President and CEO of Koya Medical. “We’re 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 program custom treatment options. Koya previously received FDA 510(k) clearance for the Dayspring flagship product for both upper and lower extremity lymphedema. Koya Medical is committed to providing patients and caregivers a complete suite of solutions that provide coordinated and comprehensive care of this chronic condition.

Visit koyamedical.com for more information.