Eoflow said Friday that it has won breakthrough device designation (BDD) from the U.S. Food and Drug Administration for EOPancreas, a wearable disposable artificial pancreas system.
|Eoflow's wearable disposable artificial pancreas system EOPancreas|
The device integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion to ensure that the patient’s blood glucose level stays within the normal range most of the time with little input from the patient.
It also continuously measures the blood sugar of the user and automatically injects the right insulin dosage. If commercialized, the company expects that the product will become the world’s first all-in-one wearable artificial pancreas system.
With the approval, the company has become the first medical device manufacturer to receive the BDD designation.
The BDD is an expedited screening system that the FDA designates through a preliminary examination for products that the agency considers to have a high market demand among non-existent medical devices. All companies designated with the BDD will receive many benefits, such as priority review and additional review panels, which allows for a much faster product approval than a general review.
However, the selection criterion is quite difficult with only 100 products receiving BDD designation since the program began in 2016.
“The product also became the first local device to be selected by the U.S. Juvenile Diabetes Research Foundation last year for its technological innovation and product excellence,” the company said.
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