Pops Diabetes Care said this week that the FDA cleared its Pops! one blood glucose monitoring system. The Minneapolis-based company’s device can be attached directly to the back of a mobile phone and interacts with the user through a coaching app. The Pops! one system also allows users to review their blood glucose trends and […]
Dexcom completes $850m debt offering
Dexcom (NSDQ:DXCM) said that it completed the sale of $850 million of 0.75% convertible senior notes due 2023. The San Diego, Calif.-based company expects to reel in roughly $836 million in net proceeds from the offering. Dexcom used $35.1 million of the offering’s proceeds to pay the cost of the convertible note hedge transactions as described […]
Diabeloop wins CE Mark for hybrid closed-loop diabetes management system
Diabeloop won CE Mark clearance in the European Union this month for its hybrid closed-loop diabetes management system, DBLG1. The Paris-based company hopes to launch its “artificial pancreas” system for adults with Type I diabetes in Europe by the second quarter in 2019. Diabeloop’s system connects Dexcom‘s (NSDQ:DXCM) G6 continuous glucose monitor, Kaleido’s patch insulin […]
FDA issues revised draft guidances for blood glucose monitors
The FDA issued two revised draft guidances today relating to over-the-counter and prescription blood glucose monitors. The new documents, which are intended to update guidances issued in 2016, were based on feedback from stakeholders, who requested more clarification on design considerations and recommended standards, according to the U.S. regulatory agency. The guidances include recommendations for […]
Dexcom prices $750m debt offering
Dexcom (NSDQ:DXCM) today priced its $750 million offering of convertible senior notes due 2023 which is slated to be offered to qualified institutional buyers. The San Diego, Calif.-based company said that it will also offer a 13-day option to buy up to an additional $100 million aggregate principal amount of notes to purchasers in the offering. […]
Dexcom readies $750m debt offering
Dexcom (NSDQ:DXCM) said yesterday that it plans to offer $750 million in convertible senior notes due 2023 in a private placement to institutional buyers. The San Diego, Calif.-based company also expects to give buyers a 13-day option to buy up to an additional $100 million aggregate principal amount of notes. The notes will mature on Dec. […]
Valeritas touts use of insulin delivery device with physician-driven titration algorithm
Valeritas (NSDQ:VLRX) touted today the publication of a retrospective analysis showing that adults with Type 2 diabetes experienced improved glycemic control using the V-Go wearable insulin delivery device and a physician-driven titration algorithm. The proof-of-concept study was designed to assess the safety and efficacy of a doctor-driven insulin titration algorithm in adults who were prescribed V-Go. […]
Medtronic’s insulin pumps highlighted in medtech injury report
A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps. Over the […]
Medtronic inks deal to acquire nutrition tech group Nutrino Health
Medtronic (NYSE:MDT) said today that it inked a deal to acquire nutrition tech company Nutrino Health for an undisclosed amount, with plans on integrating it into the company’s diabetes division. Nutrino Health provides nutrition-related data services, analytics and technologies, Fridley, Minn.-based Medtronic said. The company added that it plans to integrate Nutrino’s food analysis infrastructure, nutrition […]
Insulet’s Omnipod Dash system lands ISO cert for data security
Insulet (NSDQ:PODD) said this week that it won ISO 27001 certification for its Omnipod Dash product, meeting the international standard for best practice in an information security management system. The Billerica, Mass.-based company’s Omnipod Dash system wirelessly connects Insulet’s Personal Diabetes Manager with a tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using […]
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