CRF Health Gains FDA Clearance of Wireless Glucometer

Plymouth Meeting, PA – CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, today announced the launch and FDA clearance of its Entra BLE Smart wireless glucose meter. This new glucometer utilizes next-generation, low-energy Bluetooth technology delivering extended battery life and enhanced connectivity compared to traditional Bluetooth devices. Diabetes patients who need to perform multiple blood glucose readings each day will benefit from improved battery life contributing to a reduction in their day-to-day burden, whether they are simply managing their condition or participating in a clinical trial.

The Entra BLE Smart also received CE approval in December 2016 and can now be used throughout the EU. It is the latest in the company’s wide range of wireless glucose monitoring systems, which have quickly become the de facto standard for clinical research across the world. Its comprehensive product line also includes MyGlucoHealth, the company’s flagship Bluetooth classic meter which was introduced in 2009 and now has regulatory approval in over 50 countries, as well as the recently FDA-cleared MyGlucoHealth Wireless Cellular Meter which offer data transmission directly via cellular networks without the need for a paired device.
 
Rapid testing results available in just three seconds combined with the smallest blood sample size (0.3μL) and automatic coding of test strips, CRF Health’s glucose meters are among the most technologically-advanced on the market. All are integrated with CRF Health’s TrialMax eCOA platform for clinical trials, or MyHealthPoint, the company’s real-time online data collection portal for the healthcare market, giving clinicians real-time visibility of data, allowing them to proactively collect, monitor and manage their patients’ diabetes, improving care and long term outcomes.

“As an early innovator in digital health, CRF Health has a proven track record in manufacturing and developing patient-friendly, scalable and cost effective wireless glucose meter solutions. The introduction of the Entra BLE Smart builds on the clinical research pedigree of our existing systems, which tens of thousands of patients around the world have already experienced,” said Richard Strobridge, VP Healthcare at CRF Health. “Gaining FDA clearance for this new device is an important step in our continuing mission to manage and deliver actionable patient data to clinicians, care givers and clinical trial sponsors around the world.”

Following CRF Health’s acquisition of the company, Entra Health’s product and service offerings have been integrated into CRF Health’s portfolio. Bringing the solutions together will extend the connectivity of CRF Health’s technology, playing a vital role in the company’s vision of making the patient the center piece of the healthcare and clinical trial process.
 
For further information on CRF Health, please visit www.crfhealth.com.

About CRF Health
CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health’s TrialMax platform consistently demonstrates the industry’s highest data accuracy, patient and site compliance, and patient retention.

CRF Health’s eSource solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax platform includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes), and ClinROs (Clinician or Rater Reported Outcomes), PerfROs (Performance Reported Outcomes) and features TrialConsent, an electronic solution for collecting informed consent in clinical trials.