Masimo Introduces Pronto-7 Internationally, Lifts Recall

Masimo has lifted the voluntary product recall the company imposed on the noninvasive finger sensor of its Pronto-7 handheld device to improve the product's performance in low ambient temperatures. The Pronto-7 and new finger sensors are pending FDA 510(k) clearance in the United States.
 New product features and enhancements include the addition of Max Sensitivity Mode that allows measurement over a broader range of patients. The addition of three noninvasive sensor sizes permits the instrument to be used on a broader range of finger diameters. Each of the new sensors is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White).
 As part of Masimo's premarket testing and verification process, over 14,443 Pronto-7 measurements were performed on 1,443 subjects at 14 sites and compared to hemoglobin measurements from a venous blood sample analyzed on a hematology analyzer (Coulter counter). This testing resulted in a product specification of 1.0 g/dL for normal sensitivity mode and 1.1 g/dL for max sensitivity mode. While not a regulatory requirement, prior to lifting the voluntary recall, Masimo elected to perform additional testing on Pronto-7 devices and sensors produced at a Masimo manufacturing facility. This additional testing included 474 subjects in three outpatient clinic-type environments. The hemoglobin measurements from the Pronto-7 and a point-of-care device using capillary blood (Hemocue) were compared to hemoglobin measurements from a venous blood sample analyzed on a Coulter counter. The Hemocue showed a bias of -0.1 g/dL and a standard deviation of 1.6 g/dL, while the Pronto-7 showed a bias of was -0.1 g/dL and a standard deviation of 1.1 g/dL. Based on the clinical results obtained and positive feedback from clinicians, Masimo has initiated international availability of Pronto-7 in Europe, Middle East, Africa, Canada, South America, and Asia.