Innovative Blood Glucose Monitoring System Approved
By LabMedica International staff writers Posted on 11 Jan 2016 |
Image: Dario Blood Glucose Monitoring System (Photo courtesy of Dario).
A smartphone-based blood glucose monitor with unique all-in-one design has been cleared for launch in the world's largest diabetes market.
The Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The compact all-in-one system helps people with diabetes monitor their blood sugar levels and proactively manage their diabetes using their smartphone.
The Labstyle’s Dario Blood Glucose Monitoring System (Caesarea, Israel) connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one easy to carry device to take blood glucose measurements on the spot. Unlike conventional glucose monitors, there is no carrying case or batteries to replace. Dario provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes. Dario's web interface also makes it easy for users to share health information with healthcare providers and relatives.
The United States Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher. Erez Raphael, BA, the CEO and president of LabStyle Innovations Corp., that developed the Dario system, said, “We are very pleased and excited to receive the FDA's marketing clearance for Dario. While Dario has already been approved in numerous countries throughout the world, the USA is the single largest market in the global blood glucose monitoring market. We believe sales in the USA will have a substantial impact on LabStyle's financial performance and value.”
Related Links:
Dario
United States Food and Drug Administration
The Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The compact all-in-one system helps people with diabetes monitor their blood sugar levels and proactively manage their diabetes using their smartphone.
The Labstyle’s Dario Blood Glucose Monitoring System (Caesarea, Israel) connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one easy to carry device to take blood glucose measurements on the spot. Unlike conventional glucose monitors, there is no carrying case or batteries to replace. Dario provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes. Dario's web interface also makes it easy for users to share health information with healthcare providers and relatives.
The United States Food and Drug Administration (FDA; Silver Springs, MD, USA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher. Erez Raphael, BA, the CEO and president of LabStyle Innovations Corp., that developed the Dario system, said, “We are very pleased and excited to receive the FDA's marketing clearance for Dario. While Dario has already been approved in numerous countries throughout the world, the USA is the single largest market in the global blood glucose monitoring market. We believe sales in the USA will have a substantial impact on LabStyle's financial performance and value.”
Related Links:
Dario
United States Food and Drug Administration
Latest Clinical Chem. News
- 3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models
- POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
- Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
- New Blood Testing Method Detects Potent Opioids in Under Three Minutes
- Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step
- Pain-Free, Low-Cost, Sensitive, Radiation-Free Device Detects Breast Cancer in Urine
- Spit Test Detects Breast Cancer in Five Seconds
- Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC
- First-Of-Its-Kind Handheld Device Accurately Detects Fentanyl in Urine within Seconds
- New Fluorescent Sensor Array Lights up Alzheimer’s-Related Proteins for Earlier Detection
- Automated Mass Spectrometry-Based Clinical Analyzer Could Transform Lab Testing
- Highly Sensitive pH Sensor to Aid Detection of Cancers and Vector-Borne Viruses
- Non-Invasive Sensor Monitors Changes in Saliva Compositions to Rapidly Diagnose Diabetes
- Breakthrough Immunoassays to Aid in Risk Assessment of Preeclampsia
- Urine Test for Monitoring Changes in Kidney Health Markers Can Predict New-Onset Heart Failure
- AACC Releases Comprehensive Diabetes Testing Guidelines