Ivenix said today that its infusion system won 510(k) clearance from the FDA. The large-volume pump and infusion system features a “smartphone-like” user interface and a suite of administration tools to remotely monitor infusions, according to Ivenix. The Boston-based company reported that infusion-related adverse drug events make up more than $2 million in healthcare costs […]
Medtronic, Tidepool ink deal for interoperable, automated insulin pump
Medtronic (NYSE:MDT) and nonprofit org Tidepool announced last week that the groups will work together to develop an interoperable, automated insulin delivery system. The medtech giant reported that it plans to build a Bluetooth-enabled MiniMed pump that is compatible with Tidepool’s Loop app, an open-source app for automated insulin delivery. Both companies plan to work […]
Beta Bionics touts results of bionic pancreas system study
Beta Bionics’ iLet bionic pancreas system significantly increased the percentage of time that adults with Type 1 diabetes spent with glucose levels between 70–180 mg/dl when compared to usual care therapy, according to a new study. The study’s results also suggest that the iLet, using either the Senseonics (NYSE:SENS) Eversense continuous glucose monitoring system (CGM) […]
Could this agreement boost continuous glucose monitor use?
An international panel of patients, physicians and researchers has agreed upon evidence-based target glycemic ranges for people who use continuous glucose monitors (CGMs) to control their diabetes. Announced today at the American Diabetes Association (ADA) conference in San Francisco, the International Consensus on Time-in-Range (TIR) was based on data from large pre-CGM clinical trials, CGM […]
7 MD&M East exhibitors you need to know
MD&M East is one of the largest medical device manufacturing events on the East Coast. Its organizer Informa Markets expects more than 8,000 advanced manufacturing professionals at this year’s event – June 11–13 in New York City. A show such as MD&M East allows officials from medtech companies large and small to network with the constellation […]
Windtree, Eleison tout feasibility study results
Windtree Therapeutics (OTCQB:WINT) and Eleison Pharmaceuticals have announced positive results of a feasibility study using Windtree’s aerosol delivery system (ADS) to deliver Eleison’s inhaled lipid cisplatin (ILC) for lung cancer. In the study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in […]
Plaintiffs appeal Ocular Therapeutix win in shareholder lawsuit
Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device. The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Enable Injections inks deal with Sanofi for drug delivery platform
Enable Injections said today that it inked a partnership with Sanofi for its enFuse drug delivery platform. Cincinnati-based Enable Injections developed the enFuse device to enable patient-administered subcutaneous delivery of high-volume therapeutics outside of the hospital. The on-body drug delivery platform has a self-contained drug transfer system that is compatible with standard syringes and vial […]
Kurve Technology wins DoD contract for drug delivery tech
Kurve Technology won a U.S. Defense Dept. contract to test a new formulation for combating traumatic brain injuries. The Mill Creek, Wash.-based company makes a controlled particle dispersion device designed to deliver liquid drugs through a controlled, turbulent flow, according to the company’s website. Its ViaNase electronic atomizer can deliver most drug compounds through the […]
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