Insulet (Nasdaq:PODD) announced today that it received CE mark approval in Europe for its Omnipod 5 automated insulin delivery system. Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts-based Insulet said it represents the first CE-marked tubeless hybrid closed loop system. The latest-generation Omnipod 5 […]
Auto-injectors
CISA warns on cybersecurity vulnerabilities for certain Baxter infusion pumps
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued a warning on some Baxter (NYSE:BAX) infusion pumps. Sigma and Baxter Spectrum infusion pumps are included in a CISA notice over remotely exploitable vulnerabilities. Those vulnerabilities include: missing description of sensitive data, use of externally controlled format string and missing authentication for critical functions. The […]
Analysts see multi-year transition to growth for Embecta
Embecta (Nasdaq:EMBC), the BD diabetes business spinoff, may take a few years to move into a growth phase, analysts say. BTIG analysts Marie Thibault and Sam Eiber wrote a report labeling Embecta as a “Neutral” option on the market. BD initially announced it would spin off its diabetes business in 2021, finally completing the move […]
WHO delivers insulin pens to Ukraine hospitals with support from Novo Nordisk
The World Health Organization (WHO) announced that it delivered more than 26 metric tonnes of insulin pens to Ukraine. WHO distributed approximately 57,320 pounds of insulin pens (more than 370,000 total pens) to hospitals throughout Ukraine. It represents part of an effort to help those with diabetes in the country during the ongoing humanitarian crisis. […]
Study backs next-gen Medtronic MiniMed 780G insulin pump
Medtronic (NYSE:MDT) today announced positive results from a study of its next-generation MiniMed 780G automated insulin delivery system. Results from the ADAPT study, published in The Lancet Diabetes & Endocrinology, demonstrated improved glycemic control and treatment satisfaction among users of MiniMed 780G. The MiniMed 780G system is available in more than 60 countries. It is currently […]
FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures
Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus, or prolonged seizures. Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Rafa’s Midazolam 10mg autoinjector received FDA indication for […]
Second Sight Medical merges with Nano Precision Medical, rebrands as Vivani Medical
Second Sight Medical (Nasdaq:EYES) announced today that it completed its merger with Nano Precision Medical and rebranded. In February, the two companies entered into a definitive agreement under which Nano Precision Medical (NPM) would merge with a wholly-owned subsidiary of Second Sight in an all-stock transaction, with NPM as the surviving company under Second Sight’s […]
FDA clears Insulet Omnipod 5 for children two years and older
Insulet (Nasdaq:PODD) announced today that the FDA cleared its Omnipod 5 for individuals aged two years and older with type 1 diabetes. Acton, Massachusetts-based Insulet’s Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January. That clearance covered individuals six years of age and older. In June, […]
Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
Tandem Diabetes Care (Nasdaq:TNDM) announced today that its users have delivered more than 1 million insulin boluses using its app. Users of the t:connect app feature on their mobile devices have reached the 1 million insulin bolus milestone with the t:slim X2 insulin pump within the first month following its commercial release. San Diego-based Tandem […]
Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition
Wells Fargo downgraded Tandem Diabetes Care (Nasdaq:TNDM) as competitors apply pressure to the automated insulin delivery technology developer. According to SeekingAlpha, analysts led by Larry Biegelsen moved Tandem from “Overweight” to “Underweight” due to bullish expectations on Wall Street as the company’s competition, including Insulet and Medtronic, come to the fore. The street responded in kind, with […]
