Koya Medical has received Food and Drug Administration (FDA) 510(k) clearance for its Dayspring Lite treatment for lymphedema and venous disease, it announces.
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 lymphedema regimen. It uses the same Flexframe technology and smart, rechargeable, handheld 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, a media release from Koya Medical explains.
“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. 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.”
— Andy Doraiswamy, PhD, Founder, President and CEO of Koya Medical
The Dayspring system includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary Flexframe technology; a smart, rechargeable, handheld 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, per the release.
[Source(s): Koya Medical, Business Wire]