Ypsomed announced today that Eli Lilly (NYSE:LLY) elected to stop their joint project to enter the U.S. insulin pump market. In November 2020, the companies entered into a commercialization agreement. The agreement entailed registering and commercializing Ypsomed’s YpsoPump under Lilly’s branding in the U.S. Ypsomed said that, over the past two years, it customized its […]
Drug Pumps
FDA clears Mallya smart insulin pen device from Biocorp
Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens. Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected […]
BD warns on cybersecurity risk with BodyGuard infusion pumps
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued an advisory regarding infusion pumps from BD (NYSE:BD). CISA’s advisory concerns the BD BodyGuard infusion pumps. They may contain a vulnerability in the form of a missing protection mechanism for an alternate hardware interface. Get the full story at our sister site, Drug Delivery Business News.
Ypsomed, CamDiab launch first automated insulin dosing system with Abbott FreeStyle Libre 3
Ypsomed announced that its mylife Loop now has authorization to work with the Abbott FreeStyle Libre 3 sensor in Germany. The Ypsomed mylife YpsoPump combines with the CamDiab mylife CamAPS FX algorithm and FreeStyle Libre 3. Together, they form an intelligent and automated insulin delivery (AID) system for people with type 1 diabetes. Users can […]
Tandem stock ticks up after Wells Fargo upgrade
Tandem Diabetes Care (Nasdaq:TNDM) shares ticked up today after Wells Fargo declared it “Equal Weight,” an improvement from “Underweight.” Shares of TNDM rose 8.3% at $42.81 apiece in midday trading today. MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 6.8%. Get the full story at our […]
Insulet issues device correction on Omnipod 5 controller due to charging issue
Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system. Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 […]
Medtronic launches 7-day infusion set for insulin pumps in U.S.
Medtronic (NYSE:MDT) announced today that it launched its Medtronic Extended Infusion set for seven-day wear with insulin delivery. The Medtronic Extended Infusion Set represents the first and only infusion set labeled for wearing for up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two […]
Study supports Tandem t:slim X2 insulin pump for type 2 diabetes
Tandem Diabetes Care (Nasdaq:TNDM) announced that a study of adults with type 2 diabetes supported its automated insulin delivery system. The study evaluated adults with type 2 diabetes using the t:slim X2 insulin pump with Control-IQ technology. Patients achieved improvement in all clinical endpoints with the technology, which currently does not hold approval for type […]
Insulet warns of battery issues with some Omnipod Dash PDM devices
Insulet (Nasdaq:PODD) recently issued a voluntary global safety notice to warn of battery problems with its Omnipod Dash system. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash […]
Insulet stock rises on Street-beating Q3, raised sales guidance
Insulet (Nasdaq:PODD) shares ticked up after hours today on third-quarter results that came in ahead of the consensus forecast. Shares of PODD rose 8.1% at $276 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 3.8%. The Acton, […]
Tandem stock dives on Q3 misses, reduced guidance
Tandem Diabetes Care (Nasdaq:TNDM) shares took a big hit after hours on third-quarter results that missed the consensus forecast. Shares of TNDM. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.3%. The San Diego-based company posted losses of nearly $49 million for the […]