Diabetes-focused medical device developer Smart Meter said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its iGlucose blood glucose monitoring system.
The New York-based company’s iGlucose system is a subscription-free glucose meter and diabetes health managements system which automatically transmits data to a cloud-based personalized web portal. The system also allows for real-time communication between the diabetes patient and their designated caretakers, the company said.
Smart Meter said its iGlucose meter comes ready out-of-the-box to communicate with the cloud, only requiring a simple registration before use. Data collected is integrated into charts and graphs and presented as actionable data that the company said can aid physicians in customizing patient care.
“While more than 400 million people have diabetes globally, managing it can be a lonely and frustrating journey for them if their healthcare professionals and loved ones aren’t adequately involved in day-to-day care. Being digitally connected with their Circle of Care has proven to turn the tide for many people with diabetes. The web-connected glucose meters available today have shown limited results because they’re so complicated to use. We’re excited about our regulatory approvals because the iGlucose System’s ease of use makes it possible for family, friends, and healthcare professionals to be truly engaged and support the person with diabetes in their daily diabetes management,” CEO Cliff McIntosh said in a press release.
The company said it plans to launch the iGlucose in the US and U.K. some time this year.