Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently be […]
Insulet touts full market launch of mobile apps for Omnipod Dash
Insulet (NSDQ:PODD) touted the full market launch of the Omnipod Display and Omnipod View apps for people using the company’s Omnipod Dash system. The Display app enables users to display data from their Personal Diabetes Manager device onto their smartphones. The View app gives caregivers and family members the option to remotely monitor Omnipod Dash system […]
Omnipod Dash sales drive Insulet Q2 results
Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or $0.02 per share, on sales of $177.1 million for the three months ended June 30, 2019, for a bottom-line […]
Bigfoot Biomedical inks deal with Pittsburgh health system
Bigfoot Biomedical today announced an agreement with Pittsburgh-based Allegheny Health Network (AHN) to further develop Bigfoot’s Unity investigational insulin delivery wireless platform. The diabetes startup described Unity as a first-in-kind data-driven solution for optimizing insulin dosing and delivery. Bigfoot will work alongside AHN endocrinologists and primary care doctors to refine Unity’s clinical workflow features. Get the full […]
Dexcom posts Street-beating Q2 earnings
Dexcom (NSDQ:DXCM) posted second-quarter results this evening that beat the consensus forecast on Wall Street, and raised its outlook for the rest of the year. The San Diego–based continuous glucose monitoring (CGM) technology company reported a loss of $10.5 million, or $0.12 per share, on sales of $336.4 million for the three months ended June 30. […]
Livongo share prices double after upsized $356m IPO
Investors added nearly 50% to the share price for Livongo Health (NSDQ:LVGO) today after it raised $355 million with its initial public offering after a last-minute upsizing. The Mountain View, Calif.-based company, which developed a digital health platform to manage chronic diseases, said earlier this week that it planned to float 10.7 million shares at $24 […]
Eli Lilly, Aptar win FDA approval for nasal glucagon powder
Eli Lilly (NYSE:LLY) and AptarGroup (NYSE:ATR) today won FDA approval for the first injection-free glucagon for treating severe low blood sugar in diabetes patients. The federal safety watchdog’s approval, of Lilly’s Baqsimi nasal powder and the delivery device developed by Aptar for treating severe hypoglycemia, was based on two studies comparing a single dose of Baqsimi […]
Livongo boosts IPO to $268m midpoint
Livongo Health yesterday boosted the range on its pending initial public offering, saying the flotation would now fetch nearly $268 million at the midpoint. The Mountain View, Calif.-based company developed a digital health platform to manage chronic diseases, selecting diabetes as its first target. After a series of upsizing announcements, Livongo yesterday said it plans […]
Medtronic bids for expanded FDA indication for Guardian Sensor 3
Medtronic (NYSE:MDT) said it asked the FDA for an expanded indication for its Guardian Sensor 3 device that would open the glucose sensor up for Medicare reimbursement. The Fridley, Minn.-based medtech titan said it filed for pre-market approval of non-adjunctive labeling for Guardian Sensor 3 for use with its MiniMed 670G insulin management system. If […]
Senseonics prices $107m worth of stock, debt offerings
Senseonics (NYSE:SENS) today priced stock and debt offerings worth a total of at least $107 million. Germantown, Md.-based Senseonics, which developed the Eversense implantable CGM, announced the offerings yesterday. Get the full story at our sister site, Drug Delivery Business News
Report: Literal killer app prompted Medtronic MiniMed recall
Two years ago, researchers discovered vulnerabilities in Medtronic’s MiniMed and MiniMed Paradigm insulin pump lines that could allow hackers to remotely withhold insulin or trigger a potentially lethal overdose. But after months of negotiations with Medtronic and regulators with no fix forthcoming, the researchers decided to build a smartphone app that could show how the […]
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