LabStyle Innovations Corp. in Caesarea, Israel, developer of a mobile and cloud-based system for diabetes management, filed for pre-market notification of its system with the U.S. Food and Drug Administration. Pre-market notification, once granted by FDA, clears medical devices for marketing in the U.S.
LabStyle Innovations created the Dario system that combines a small glucose meter with a blood pricking needle and test strip dispenser to measure blood glucose levels. The glucose meter connects to the patient’s smartphone, and synchronizes with an app where the patient can log other data on diet, exercise, and even mood. The app looks up carb levels for food in a stored database.
The app, says LabStyle, provides statistical or graphic feedback, which the patient can monitor against personal maintenance goals or share with others, such as caregiver or physician. The feedback provides an overview of blood glucose measurements as well as ability to hit glucose level targets. The patient or others granted access can also retrieve the detail-level logs, if needed, from a secure portal.
The Dario system received received CE mark certification in September 2013, indicating approval for marketing in Europe. LabStyle introduced the iPhone app in United Kingdom, Australia, and New Zealand last month, with Italy and Belgium scheduled for the first quarter of 2014. The company expects to release the Android version in the U.K., New Zealand, Australia, Italy and Belgium also in the first quarter of 2014. The blood glucose monitoring device is expected to be released in the U.K. and Italy during first quarter 2014.
For pre-market clearance, FDA requires submitters to demonstrate that their device is substantially equivalent, i.e., at least as safe and effective, as a current legally marketed device. Companies need to compare their device to one or more similar legally marketed devices and make and support their claims of equivalency.
In September 2013, FDA announced it would concentrate its regulatory oversight on the fraction of medical apps that can pose a risk to consumers if they do not work as intended, using the legal definition of medical device to determine that threshold. Included in that definition are instruments designed to diagnose, mitigate, treat, or prevent a disease.
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