Koya Medical said today that it has won FDA 510(k) clearance for its Dayspring Lite treatment for lymphedema and venous disease.
The Oakland, California–based company’s Dayspring family of treatments enables people to be mobile during active compression therapy — unlike traditional wall-tethered compression pumps.
Dayspring Lite is a prescription-only treatment for people who need basic active compression for their lymphedema regimen. It allows patients to select and monitor one of three standard treatment intensities through the Koya app. If the patient’s needs evolve to require calibration and additional customization, Koya Medical can help them 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,” Koya Medical founder and CEO Andy Doraiswamy said in a news release. “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.”