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In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss a pair of topics making headlines in recent weeks: the US Food and Drug Administration’s 510(k) clearance for the Accu-Chek Solo micropump system and Abbott’s acquisition of Bigfoot Biomedical.
Announced by Roche on August 23, 2023, the FDA’s 510(k) clearance for the Accu-Chek Solo micro pump system indicates the device for use in people with aged 2 years and older with type 1 diabetes. Worn as a patch directly on the body and controlled wirelessly from a touchscreen handheld device, the system consists of a disposable adhesive pump holder, an infusion cannula, a reservoir, a reusable pump base, and a reusable handheld diabetes manager equipped with an integrated Accu-Chek guide glucose meter and bolus calculator.1,2
“We are pleased to see our latest innovative pump system cleared by the FDA”, said Marcel Gmünder, global head of Roche Diabetes Care.1 “We are proud of our teams who have been steadfast in their activities to accomplish this important achievement for our Accu-Chek Solo system and appreciate the close collaboration with the authority.”
On September 5, 2023, Abbott and Bigfoot Biomedical announced a definitive agreement for Abbott to acquire Bigfoot, with the deal expected to close in the third quarter of 2023 and no financial terms disclosed at the time of announcement. Developers of Bigfoot Unity, a system designed to work exclusively with Abbott’s FreeStyle Libre technology, Abbott and Bigfoot have worked together on connected diabetes solutions dating back to 2017.3
"The acquisition of Bigfoot Biomedical will combine two leaders in different aspects of diabetes care: continuous glucose monitoring and insulin dosing support," said Jared Watkin, senior vice president of Abbott's Diabetes Care business.3 "Bringing our companies together will allow us to further develop connected solutions for making diabetes management even more personal and precise."