Masimo Pronto-7™ Receives China and South Korea Regulatory Clearances

Masimo

announced the China State Food and Drug Administration and South Korea Food and Drug Administration regulatory clearances of Masimo Pronto-7™ – enabling clinicians throughout both countries to conveniently and noninvasively measure total hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index. Earlier this year, Masimo announced U.S. Food and Drug Administration 510(k) clearance and full market release of the new Pronto-7, which includes expanded sensor size options to accommodate a wider range of finger sizes and the addition of a Max Sensitivity Mode. Su Lei, director of ICU at China's General Hospital of Guangzhou Military Command, praised the Pronto-7 as a time- and potentially life-saving device. "In our ICU, Pronto-7 helps to get the SpHb value in an extremely quick way," Lei said. "The Pronto-7 quickly determines the hemoglobin levels for acute and critically ill patients and helps our staff with early intervention when necessary."