The China State Food and Drug Administration and South Korea Food and Drug Administration have approved Masimo's palm-sized handheld device, Pronto-7.
The Pronto-7 has dimensions of just 13 cm x 7.2 cm x 2.5 cm and is designed for noninvasive spot-checking of total hemoglobin (SpHb), SpO2, pulse rate, and perfusion index in less than one minute.
Masimo founder and CEO Joe Kiani said regulatory clearance of the Pronto-7 in China and South Korea will provide 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," Kiani added.
The company said Pronto-7 handheld device has also received the US Food and Drug Administration approval.