The U.S. Dept. of Homeland Security (DHS) issued a medical advisory to warn of vulnerabilities with the Insulet (NSDQ:PODD) Omnipod insulin management system. According to the advisory, the affected insulin pumps are designed to communicate using a wireless RF with Insulet’s personal diabetes manager device, but the RF communication protocol does not properly implement authentication or […]
Insulet pauses OmniPod study due to software problem
Insulet (NSDQ:PODD) today said it is putting a halt on its pivotal study of its Omnipod Horizon Automated Glucose Control System study because of a software anomaly. The company is correcting an issue that could result in the system using an incorrect glucose value that has the potential to impact insulin delivery, according to the company. […]
Insulet down after hours on Q4 sales beat, bottom-line slide
Insulet (NSDQ:PODD) shares took a further hit today after sliding in the market following the release of the company’s quarterly earnings. The company’s shares sunk after-hours yesterday on fourth-quarter results that beat the consensus forecast for revenue but appeared to miss on earnings. Today, shares of PODD are down -8.4% at $180.18 per share in mid-afternoon […]
Insulet partners with Abbott and Dexcom on automated insulin delivery
Abbott (NYSE:ABT) and Dexcom (NSDQ:DXCM) each announced today that they are partnering with Insulet (NSDQ:PODD) to feed blood glucose monitor data into an automated insulin delivery system. For Acton, Mass.–based Insulet, the agreements are a boost for its next-generation Omnipod Horizon automated insulin delivery system, which is presently an investigational device in the United States. The idea of […]
Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch
Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today. During its ongoing quality management process, Insulet officials discovered that the PDMs on rare occasions will suggest an inaccurate bolus amount based on a blood […]
The 10 greatest medtech advances of the 2010s
From disposable endoscopes to TAVR to robotic surgery, there’s a whole host of medtech advances widely available now that weren’t around much 10 years ago. “In terms of technological advances, I would put this past decade as one of the most important for medical technology. From connected devices and robotics, to advances in material sciences […]
Insulet Q3 earnings beat The Street despite bottom-line slide
Insulet (NSDQ:PODD) shares are rising today on third-quarter results that topped the consensus forecast, despite a dip in profits. The Acton, Mass.–based company posted profits of $852,000, or 1¢ per share, on sales of $192.1 million for the three months ended Sept. 30, for a 48.6% bottom-line slide on sales growth of 27.1%. Get the full […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal year. We […]
Insulet wins FDA nod for Omnipod with Novo Nordisk’s Fiasp insulin
Insulet (NSDQ:PODD) said last week that it won FDA clearance for the use of Novo Nordisk‘s (NYSE:NVO) Fiasp insulin with the Omnipod insulin management platform. Acton, Mass.-based Insulet said it completed extensive testing to ensure that Fiasp is safe and usable with the Omnipod and Omnipod Dash systems. It’s the first insulin pump in the U.S. […]
FDA clears Insulet’s OmniPod Dash as insulin pump alternative
Insulet (NSDQ:PODD) said today that it won FDA clearance to market its Omnipod Dash alternate controller-enabled (ACE) infusion pump as an integrated insulin pump. The Acton, Mass.-based company received FDA 510(k) clearance for the Omnipod Dash in June 2018 and launched the device earlier this year. The latest indication states that the pump can reliably and securely communicate […]
Insulet prices $700m offering
Insulet (NSDQ:PODD) today priced a private placement of $700 million in convertible senior notes due 2026. The offering is slated to close on Sept. 6. The Acton, Mass.-based company said in a press release it also gave initial purchasers an option to buy up to an additional $100 million in notes. Get the full story at our sister […]
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