US-based diabetes technology company, Tandem Diabetes Care has received US Food and Drug Administration (FDA) clearance for its Tandem Mobi insulin delivery system.
The device, which is expected to become available on the market towards the end of 2023, has been dubbed by the company as the ‘world’s smallest insulin pump’. Full commercial availability is planned for early 2024.
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By GlobalDataFollowing the news of the clearance, Tandem Diabetes CEO, John Sheridan said: “Testing the limits of pump miniaturization, Tandem Mobi joins the t:slim X2 pump in our family of insulin delivery solutions bringing new options in wearability, the flexibility to disconnect, and full phone control.”
Tandem Mobi will come with control-IQ technology, a hybrid-closed loop algorithm to be used by people with type 1 diabetes from the age of six. The technology uses compatible continuous glucose monitoring (CGM) sensor values to forecast glucose levels 30 minutes ahead and adjust insulin delivery every 5 minutes to help prevent highs and lows. Users will also be able to manually administer insulin for meals.
The company’s share price jumped almost 5 points from 24.76 cents a share on Monday 10 July to 29.10 cents a share on Tuesday the 11 July when the FDA clearance was announced. To date, the share price was below the average and low market sentiment.
According to the World Health Organization (WHO), the population of people suffering from diabetes globally is approaching 9%, indicating that market demand for diabetes devices will grow.
In a GlobalData report, the North America Insulin Delivery market was valued at $5,010.2 million in 2015 and the market is expected to reach $8,494.4 million in 2025. Unit sales are expected to grow from 147,047,114 to 276,125,032 in the same time.