The American Diabetes Association's 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during … [Read More...]
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Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
Dance Biopharm raises $21m for insulin delivery device
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
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 … [Read More...]
In case you missed it
- U.K. says doctors should limit use of paclitaxel devices
- Blood glucose monitor dev Intuity Medical raises $26m
- Valeritas touts ADA’s inclusion of patch-like insulin delivery devices in diabetes management guidelines
- Beta Bionics starts new trial for bionic pancreas
- EuroPCR 2019: Elixir Medical touts DynamX
- EuroPCR 2019: Paclitaxel meta-analysis a ‘typhoon in a teapot’
- Ocular Therapeutix OTX-TP trial misses primary endpoint
- FDA warns against using ‘hacked’ diabetes devices
- Valeritas board approves 1-for-20 reverse split
- Thermo Fisher to buy Irish drug manufacturing site from GSK for $101m
- B. Braun pledges $1B to alleviate IV solution shortages
- DeviceTalks partners with New England Healthcare Executive Network to host mergers & acquisition panel at DeviceTalks Boston
- Valeritas shares fall despite Street-topping Q1 sales
- Glaukos posts Street-topping Q1 earnings
- Louisiana prisoners may get non-FDA-approved naltrexone implant
Clinical Trials
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here […]
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) […]
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 […]
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 […]
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 […]
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