FDA Clears Portable Insulin Pump from San Diego’s Tandem Diabetes

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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.