Ypsomed : Mylife Loop reaches important milestone toward US approval
June 20, 2024 at 01:04 am
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06/20/2024 - 7:00amPress Releases Ypsomed Group
Burgdorf - The CamAPS FX algorithm has received market authorisation from the United States Food and Drug Administration (FDA). Ypsomed congratulates its partner CamDiab on this achievement and looks forward to further expanding their global partnership. Currently, the mylife YpsoPump is undergoing review by the FDA as an interoperable insulin pump, paving the way for mylife Loop to enter the US market.
The mylife YpsoPump has been submitted to the FDA for approval.
The approval of the CamAPS FX algorithm in the US market is a significant milestone for us. People with type 1 diabetes and their families in the US will greatly benefit from our automated insulin delivery solution (AID) mylife Loop. CamAPS FX is the only approved AID algorithm with an indication for use in pregnancy. mylife Loop supports all patients in their daily diabetes management and enhances their quality of life, as our experience in Europe shows,
says Sébastien Delarive, Chief Business Officer of Ypsomed Diabetes Care.
mylife Loop has achieved leading customer satisfaction and Net Promoter Score (NPS) in Germany - a measure of how likely customers are to recommend a product or service. It has now been launched in most European countries, recently in France, Norway, Spain, and Italy, where it is achieving similar market satisfaction and penetration as in Germany. The approval process in Canada is still ongoing.
About mylife Loop
mylife Loop is a modular offering for the therapy of people with type 1 diabetes. The adaptive mylife CamAPS FX algorithm runs on personal smartphones and is approved for people with type 1 diabetes from the age of one and above in Europe. It is the only algorithm approved for pregnant women with type 1 diabetes. In the mylife Loop solution from Ypsomed, the mylife CamAPS FX algorithm is combined with the mylife YpsoPump and optionally with the FreeStyle Libre 3 from Abbott or the Dexcom G6 Continuous Glucose Monitoring System to form an advanced hybrid closed-loop system.
Know more about mylife Loop
Press release as PDF
mylife Loop reaches important milestone toward US approval(63.9 KiB)
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Ypsomed Holding AG is a Switzerland-based holding company engaged in the manufacture of injection pens for pharmaceutical and biotech companies. The Company develops and manufactures injection systems for custom-made self-administration, and markets pen needles for the treatment of diabetes, growth disorders or infertility, as well as therapeutic areas. The Company operates two business segments: Injection Systems and Diabetes Care. In the Injection Systems segment, the Company's YDS Ypsomed Delivery Systems offer a range of ready-to-use injection systems for pharmaceutical and biotech companies to administer of drugs or to develop and manufacture them in line with customer requirements. The Diabetes Care segment markets products such as pen needles or insulin pump to diabetics, doctors and health insurance providers. The Company operates its production sites in Burgdorf, Solothurn, Grenchen and Tabor, and sales and distribution network across Europe.
YPSOMED HOLDING AG 
