IRVINE, CA, USA — 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."
The Pronto-7 measures hemoglobin in less than one minute – without the needles, risk of blood contamination, hazardous medical waste, including blood contaminated sharps, laboratory analysis, and patient discomfort associated with traditional blood tests. With dimensions of just 13 cm x 7.2 cm x 2.5 cm (5.1" x 2.8" x 1") and weight of 296 grams (10.5 ounces), the palm-sized Pronto-7 puts the power of noninvasive hemoglobin spot-check testing, along with SpO2, pulse rate, and perfusion index, into any clinician's hands. The device's embedded 802.11 b/g and Bluetooth® communication capability offers wireless printing or emailing of test results. Future upgrades will allow for wireless transmission to electronic health record (EHR) systems.
Masimo Founder and CEO, Joe Kiani, stated: "Regulatory clearance of the Pronto-7 in China and South Korea will offer clinicians in those countries better ways to monitor and care for their patients. We are proud our innovative, completely noninvasive technology will enable clinicians to deliver the right care, at the right time to patients in these countries."
