The FDA has cleared the first commercial product from San Diego’s Tandem Diabetes Care, a wearable insulin pump, according to a statement today from the medical device startup. Tandem Diabetes says its “t:slim” insulin pump represents an advance in terms of practicality and ease of use for managing type 1 diabetes—particularly for people who manage their diabetes with multiple daily injections.
As I reported in August, when Tandem Diabetes raised $12 million in venture funding, the company applied for FDA clearance under 510(k), a section of the Food, Drug, and Cosmetic Act that allows the regulatory agency to determine if a medical device is equivalent to existing technology already cleared for use.
Tandem Diabetes says its insulin pump enables patients to get insulin continuously throughout the day using a catheter, instead of giving themselves periodic injections. In a seeming homage to Apple’s simplicity of design, the San Diego company also emphasizes the t:slim’s thin design—“the smallest insulin pump system currently available,” user-oriented features, and “vivid color touch screen.” The device also features an “eco-friendly rechargeable battery” and can be connected via a USB port to a Web application so users can upload as much as 90 days of insulin pump data or blood glucose meter data.
In its statement, the company says, “Of approximately 1.5 million people in the U.S. with type 1 diabetes, industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life.”
A Tandem Diabetes spokeswoman declined to say how much venture capital the company has raised since it was founded in 2006. By my reckoning, it is at least $77.3 million. The company’s investors include Delphi Ventures, Domain Associates, HLM Venture Partners, Second Technology Capital Investors, and TPG Biotech.
Tandem Diabetes is entering a market where many insulin pump makers already are established, including Minneapolis-based Medtronic; Bedford, MA-based Insulet; Switzerland’s Roche; New Brunswick, NJ-based Johnson & Johnson; South Korea’s Sooil; and Japan’s Nipro.
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