The FDA’s 510(k) database indicates that Tandem Diabetes Care (Nasdaq:TNDM) recently received clearance for an extended-wear infusion set. Tandem’s Capillary Biomedical (CapBio) subsidiary develops the SteadiSet Infusion Set. The wearable infusion set delivers insulin from an insulin pump to the body. Tandem — one of the largest diabetes tech companies in the world — develops the t:slim X2 and […]
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Tandem Diabetes Care subsidiary earns new FDA clearance for insulin infusion set
Tandem Diabetes Care (Nasdaq:TNDM) shared in an SEC filing that its Capillary Biomedical (CapBio) subsidiary won FDA 510(k) clearance for a new infusion set. The company won clearance for its SteadiSet Infusion Set, according to an SEC Form 8-K. It’s a wearable infusion set that delivers insulin from an insulin pump to the body. San Diego-based […]
Tandem Diabetes Care acquires infusion set maker Capillary Biomedical
Tandem Diabetes Care (Nasdaq:TNDM) announced that it acquired infusion set developer Capillary Biomedical. San Diego-based Tandem, a global insulin delivery and diabetes technology company, announced its intention to acquire Irvine, California-based Capillary last week. Financial terms for the deal were not disclosed. “Infusion sets provide people flexible options in insulin pump wearability, and we are […]
FDA grants IDE approval for Capillary Biomedical’s 7-day-wear infusion set
Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology. Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability. The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated […]
Capillary Biomedical raises $3m to support insulin infusion tech
Capillary Biomedical said today that it raised $2.9 million in a seed funding round to support regulatory filings and the launch of its insulin infusion technology. The company is gearing up for clinical trials to support a 510(k) filing and hopes to bring its SteadiSet infusion set to the market in 2019. “Our SteadiFlow infusion […]
Capillary Biomedical takes aim at ‘the Achilles heel of diabetes’
Major players in the medical device realm are in a heated race to develop the first artificial pancreas to help patients with diabetes manage the chronic condition. Just last year, Medtronic (NYSE:MDT) won FDA approval for its MiniMed 670G hybrid-closed loop system. But while companies compete for the top spot in developing what could be a […]
