POPS! Diabetes Care scores 510(k) for connected glucose monitoring system

The system also has a diabetes coach and tracking system.
By Laura Lovett

Photo credit: POPS! Diabetes Care

Last week, the FDA granted a 510(k) clearance to POPS! Diabetes Care for its latest product, the POPS! one blood glucose monitoring system. 

The system is made up of a diabetes coaching app and a small glucose meter that attaches to the back of a user’s smartphone. Users can check their glucose levels on the meter and the results will automatically transfer to the app. Users can track their glucose trends via the app and have the option to send their results to loved ones or a provider. 

POPS! Diabetes Care said in a statement that what makes this technology different than others on the market is the ability to test glucose with in-app coaching for the user. 

Why it matters

The diabetes market is quickly growing as the disease continues to impact a large number of Americans. The CDC reports that as of 2015, 9.4 percent of the US population is living with diabetes. Additionally 100 million US adults are now living with diabetes or prediabetes, according to the agency. 

Those numbers translate to a growing market for diabetes management devices. According to MarketWatch the global diabetes care devcice market is expected to reach $30.25 billion by 2022. 

The trend

The technology has been in the works for over a year. In January of 2018 the company raised a little over $1.2 million to bring the platform to the market. That funding was in addition to the $500,000 it scored from Minneapolis accelerator TreeHouse Health. 

Diabetes management and coaching tools are plentiful in the digital health world. Livongo, Fit4D, and Lark are some of the notable names in the industry. Similar to POPS! Diabetes Care, Israel-based Dario Health also released a smartphone-connected glucose meter. 

On the record 

“We are thrilled to have successfully worked with the FDA to clear this novel solution for people with diabetes. POPS! is delivering a simple experience to help people take action to achieve their goals,” Lonny Stormo, CEO of POPS! Diabetes Care, said in a statement.