Correction: the original version of this article identified this as another recall for Novum IQ. Baxter issued a notification related to a Nov. 15 recall, not a notification for a separate recall. This story has been updated. Baxter (NYSE:BAX) issued an urgent medical device correction notice regarding its Novum IQ syringe infusion pump. A few […]
Technology
Eitan Medical’s Sapphire infusion pump recall is Class I
The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind. Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, […]
ViCentra launches hybrid closed-loop insulin system with Dexcom G6
ViCentra announced today that it launched a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM. Utrecht, The Netherlands-based ViCentra designed the system to deliver insulin through its Kaleido insulin pump. The Diabeloop DBLG1 algorithm receives input from Dexcom’s G6 continuous glucose monitor. Together, they form an artificial pancreas offering flexible self […]
Baxter recalls some syringe pumps due to underdosing risk
The FDA determined that the recall of the Baxter (NYSE:BAX) Novum IQ syringe pump is Class 1, the most serious kind. Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The device is suitable for patient care in hospitals and outpatient facilities […]
Beta Bionics earns pharmacy benefit win for bionic pancreas
Beta Bionics announced that Express Scripts added its iLet bionic pancreas and associated supplies to its commercial national formulary offerings. The decision enables faster and easier access to iLet for eligible users with plans that cover the system under their pharmacy benefit. It marks more good news for Beta Bionics, which closed a $100 million […]
Dexcom raises awareness on World Diabetes Day
Dexcom (Nasdaq:DXCM) today announced its effort to raise awareness for diabetes technology on World Diabetes Day. The continuous glucose monitor (CGM) maker aims to highlight the need to improve access to diabetes technologies. It follows Abbott and Insulet as companies look to recognize World Diabetes Day and National Diabetes Awareness Month. Dexcom unveiled a first-of-its-kind […]
GlucoTrack transitions strategic focus to long-term implantable CGM
Glucotrack (Nasdaq:GCTK) President and CEO Paul V. Goode today issued a statement to shareholders outlining strategic changes. Goode’s letter to shareholders announced a redefined strategic direction. The company wants to move closer to becoming a leader in the diabetes market. According to Goode, the diabetes market has undergone a transformation over recent years. He attributed […]
Senseonics posts mixed Q3, iCGM designation expected next year
Senseonics (NYSE:SENS) shares remained mostly unchanged today on third-quarter results that came in mixed compared to the consensus forecast. Shares of SENS dipped 0.3% at 51¢ apiece before the market opened today. The Germantown, Maryland-based implantable continuous glucose monitor (CGM) maker posted losses of $24.1 million. That equals 4¢ per share on sales of $6.1 […]
NICE recommends automated insulin delivery tech rollout in UK, Medtronic, Dexcom applaud
An independent committee of the National Institute for Health and Care Excellence (NICE) voiced support for closed-loop insulin delivery. The UK-based institute recommended offering automated insulin delivery (AID) for people whose type 1 diabetes is not controlled with their current device despite best possible management with an insulin pump or real-time or intermittently scanned continuous […]
Insulet stock soars on Q3 results, Dexcom G7 integration planned for early 2024
Insulet (Nasdaq:PODD) shares got a boost from third-quarter results that came in ahead of the consensus forecast. Shares of PODD were up more than 16% at $162.94 near the end of trading today — a day after the company released results after market close. MassDevice’s MedTech 100 Index — which includes stocks of the world’s […]