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Oximeter Behavior While Using a Tourniquet

This letter is a case report presenting the behavior of an approved for marketing oximeter device under tourniquet test, while comparing it with another approved for marketing device, the Cnoga TensorTip MTX (this letter is not a clinical trial report). Pulse oximeter is aimed for measuring pulse and arterial oxygen saturation (SpO2) in the blood. The Tensor Tip MTX can measure over 15 bio parameters, among them are pulse and oxygen saturation.

New Method for Computing Optical Hemodynamic Blood Pressure

Hypertension is a major risk indicator for coronary heart diseases, renal failure, stroke and other various illnesses, and it is the primary global risk for mortality. Blood pressure measurements are essential for managing the risks resulting from hypertension. In this paper we will present a new device, the TensorTip MTX, which computes hemodynamic blood pressure noninvasively. Methods: This paper presents a technique that uses the color imaging resulting from a set of monochrome light source that traverse the tissue under consideration and is projected onto the color image sensor. A new extended solution of the Windkessel model is being displayed and provides additional insight on various functional resistances rather than a constant resistance.

Case Study for Two Noninvasive Devices Measuring Hemoglobin

This test report focuses on the evaluation of two noninvasive CFDA approved devices, TensorTip MTX and Radical-7 Pulse CO-Oximeter (Masimo Corporation, Irvine, CA), as part of the exploration of selecting a noninvasive device to be used in the Blood Bank in the Chinese People’s Liberation Army General Hospital, Beijing, China. The aim of the evaluation was to verify the accuracy of hemoglobin measurements of each device independently vs the hospital clinical laboratory reference.

Device and Method for Noninvasive Glucose Assessment

 This article presents the TensorTip Combo Glucometer (CoG), developed by Cnoga Medical Ltd, which enables to predict capillary tissue glucose concentration noninvasively. The device was clinically evaluated and compared to standard invasive blood glucose monitoring devices in few medical centers and by home users. Based on consensus error grid analysis, more than 98% of the measurements of each study were in zones A (more than 81%) and B (more than 11%). Post- marketing evaluations showed high correlations comparing the CoG to other invasive reference devices.

Evaluation of New Noninvasive Glucose Monitoring Device by Means of Standarized Meal Experiments

 This study presents the performance of the CoG (the invasive and the noninvasive components) during a standardized meal experiment. Each of the 36 participants received a device for conducting calibration at home. Thereafter, they ingested a standardized meal. Blood glucose was assessed from capillary blood samples by means of the (non)invasive device, YSI Stat 2300 plus, Contour Next at different time points. For the noninvasive (NI) CoG technology, 100% of the data pairs were found in CEG zones A (96.6%) and B (3.4%); 100% were seen in zone A for the invasive component and Contour Next. MARD was calculated to be 4.2% for Contour Next, 9.2% for the invasive component, and 14.4% for the NI component. Therefore, after appropriate individual calibration of the NI technology, both the NI and the invasive CoG components reliably tracked tissue and blood glucose values, respectively. This may enable patients with diabetes to monitor their glucose levels frequently, reliably, and most of all pain-free.

Post Marketing Study of Hemodynamic and Hematological Noninvasive Readings in a Blood Bank

 This validation test was conducted in the Fujisan Blood Bank, Fortaleza, Brazil and evaluated the noninvasive TensorTip MTX (MTX, Cnoga Medical Ltd.) readings of hemoglobin, hematocrit, red blood cells, blood pressure, and heart rate compared to reference lab device readings. A total of 334 subjects were included in the Fujisan blood bank validation (65% male, 35% female). There was no statistically significant difference between the average daily hemoglobin, hematocrit, and red blood cells measurements provided by the MTX device and the laboratory hematology analyzer. In addition, there was no significant difference between the daily blood pressure and heart rate results provided by the MTX device and the digital and manual sphygmomanometers. The error calculated between the MTX and the reference device was found to be sufficiently accurate according to the relevant standards.  

New Paradigm of Personalized Glycemic Control Using Glucose Temporal Density Histograms

 A paradigm change of the existing model of diabetes control is proposed, shifting from standardized treatment algorithms based on HbA1c follow-up to a new controlling approach that is based on the personal glucose density histogram. The histogram is an informative, detailed tool for the current patient glycemic behavior, and a future histogram can be targeted for a successful treatment. In addition, the glucose burden and the glucose severity index are proposed as informative markers for successful treatment. This is applicable to any glycemic data, by means of invasive and noninvasive glucometers.

Study Case of Remote Monitoring in the Amazon Population Years 2016-2018

A project carried out (2016-2018) on people who live on the Side River of the Amazonas, being out of the reach of any medical center, is presented in this report. Two medical boats have sailed along the Amazonas streams and measured almost 3,000 people by the TensorTip MTX, a portable device that measures more than 14 bio parameters easily and non-invasively.  Interesting results were shown, among them an improvement in Anemia from 2016 to 2018 due to a change in the nutrition. This project has started with 110 participants in 2016, growing to 943 participants in 2017, and rising to 1,824 in 2018. The willingness of people to come and measure themselves in a painless device is creating a conscious population, being aware to her medical situation and therefore improving their health.


Measuring Balance In High Altitude

Due to Hypoxia and hypobaric conditions at high altitudes, oxygen saturation decreases. Ataxia might occur and the ability to maintain balance in challenges.This study aimed to determine whether a new balance assessment test, the Zur Balance Scale (ZBS) is sensitive enough to detect changes in the balance at high altitudes.


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