Masimo received FDA 510(k) clearance for the Pronto-7 device that allows for quick and noninvasive bedside checking of total hemoglobin (SpHb), SpO2, pulse rate, and perfusion index. This is a unique tool that makes finger pricking and direct blood sampling unnecessary when watching patients’ hemoglobin levels, either in OR or in critical care settings.
The Pronto-7 already received the European CE mark back in 2010, but conducted a recall when the sensor was found to work poorly in low temperature. The issue was addressed and the device was reintroduced in August of last year.
With FDA 510(k) clearance and full commercial availability of the new Pronto-7 device, which includes expanded sensor size options to accommodate a wider range of finger sizes and the addition of a Max Sensitivity Mode, clinicians throughout the United States will be able to quickly and conveniently measure total hemoglobin, SpO2, pulse rate, and perfusion index— without removing a drop of blood.
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 in various clinical settings, including physician offices, hospitals, and clinics. Because of the device’s embedded 802.11 b/g and Bluetooth communication capability, wireless printing or emailing of test results is enabled and future upgrades will allow for wireless transmission to electronic health record (EHR) systems.
Press release: Masimo Announces FDA Clearance and Full Market Release of the New Pronto-7™ for Noninvasive Total Hemoglobin Spot-Check Measurement, Along with SpO2, Pulse Rate, and Perfusion Index; Masimo Reintroduces Pronto 7 Finger Sensor After Recall
Flashbacks: Masimo Launches Hemoglobin Hand-Held Tester Pronto-7;