Masimo (NASDAQ: MASI) announced today that it 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 U.S.
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).
Masimo Founder and CEO, Joe Kiani, stated: "We take the integrity of our design and our promises to our customers seriously. We worked through the recall until we had redesigned the sensor for Pronto-7 so that it would perform as intended in the broadest range of likely ambient temperatures. We are delighted to re-introduce the Pronto-7 and with it the potential impact of noninvasive hemoglobin spot-check measurements that offer healthcare providers around the world the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients. We believe that Pronto-7's latest features and enhancements will help clinicians to better assess more patients and make better clinical decisions based on the availability of these quick and noninvasive hemoglobin measurements."
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, South America, and Asia (except for countries requiring clearance, such as Japan).
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