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September 28, 2021
Koya Medical’s Dayspring Lite Cleared by FDA for Treatment of Lymphedema and Venous Disease
September 28, 2021—Koya Medical announced FDA 510(k) clearance for the company’s Dayspring Lite treatment for lymphedema and venous disease.
According to Koya Medical, the Dayspring family of treatments enables patients to move and be mobile during active compression therapy, allowing for improved quality of life and clinical outcomes. Dayspring Lite is a prescription-only treatment for patients who need to add basic active compression to their lymphedema regimen. The treatment uses the same Flexframe technology and smart, rechargeable, hand-held controller available in the company’s flagship Dayspring product.
The Dayspring Lite product is designed for patients who require more essential compression therapy to clear lymph fluid, but it is noncalibrated and provides less customization options than the flagship treatment. One of three standard treatment intensities can be selected by patients and monitored from the Koya app.
If calibration and additional customization are required, Koya Medical can support a seamless transition to the more advanced Dayspring therapy. Koya previously received FDA 510(k) clearance for the Dayspring flagship product for both upper and lower extremity lymphedema, noted the company.
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