HemoSphere Nano Monitor (HSNANO1)

HemoSphere Nano Monitor (HSNANO1) is an FDA 510(k)-cleared medical device (K253186) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2026. Regulation: 8.