Dance Biopharm has raised $21 million from 283 investors as part of a $59.2 million offering, according to a document filed with the SEC this week. The privately-held California-based company’s Dance 501 device stores a liquid formulation of recombinant human insulin in a hand-held electronic inhaler. Using a vibrating mesh, the device produces particles of liquid […]
Ivenix wins 510(k) clearance for infusion system
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 […]
Diabetes patients could soon replace fingersticks with Senseonics implantable CGM
Senseonics (NYSE:SENS) recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks. Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
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 […]
Dexcom, Companion Medical will share glucose, insulin data
Dexcom (NSDQ:DXCM) and Companion Medical have announced a collaboration to enable a direct exchange of continuous glucose monitoring (CGM) data from Dexcom with insulin data from InPen into both companies’ software applications. Companion made a partnership deal with Glooko this week to integrate data from its InPen smart insulin injection pen into Glooko’s diabetes data […]
Senseonics touts strong safety profile in long-term Eversense CGM post-market registry study
Senseonics (NYSE:SENS) said yesterday that is presenting long-term safety data on its Eversense CGM from a European post-market clinical follow up registry later this week, touting that results showed the device as having a strong safety profile. The presentation is slated to take place this Saturday as part of the American Diabetes Association’s Scientific Sessions in […]
Companion Medical, Glooko ink InPen insulin pen data integration deal
Companion Medical said today that it inked a partnership deal with Glooko to integrate data from its InPen smart insulin injection pen into Glooko’s diabetes data management system and mobile application. The integration will be performed through Apple‘s (NSDQ:AAPL) Apple Health application, San Diego-based Companion Medical said, and will allow users to automatically integrate insulin data […]
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