Senseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff. The company’s Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days. Get the full story […]
Tandem wins interoperable claim for insulin pump from FDA
The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose […]
GI Dynamics wins IRB approval for pivotal U.S. EndoBarrier trial
GI Dynamics (ASX:GID) said yesterday it won Institutional Review Board approval to launch a pivotal trial of its EndoBarrier device exploring its ability to treat diabetes and obesity. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat type […]
Insulet president & CEO Shacey Petrovic to participate in keynote interview at DeviceTalks Boston 2019
[Press Release] – WTWH Media and MassDevice.com announced today that Shacey Petrovic, president and CEO of Insulet (NSDQ:PODD), will be a featured keynote speaker at DeviceTalks Boston 2019. DeviceTalks Boston, which takes place on June 5-6, 2019, at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best […]
Study: Researchers develop ingestible capsule for insulin delivery
A team of researchers from MIT developed an ingestible, blueberry-sized capsule that can deliver insulin orally. In animal models, the capsule lowered blood sugar levels and performed comparably with the traditional route of insulin delivery – injections. The capsule features a small needle made of freeze-dried, compressed insulin. The needle is attached to a compressed spring, which […]
Regeneron touts one-year diabetic retinopathy data for Eylea
Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Get the full story […]
Bigfoot Biomedical, Owen Mumford ink deal for pen needles
Bigfoot Biomedical said today that it inked a commercial supply deal to include Owen Mumford‘s Pentips line of pen needles with Bigfoot’s injection system subscription bundles. Milpitas, Calif.-based Bigfoot is working on monthly subscription packages for people with insulin-requiring diabetes. The company said it selected Owen Mumford’s pen needle because of the needle’s compatibility with all disposable […]
Senseonics extends distribution agreement with Roche Diabetes Care
Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]
Senseonics wins MRI-safe FDA nod for Eversense CGM
Senseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning. “Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and […]
Valeritas’ V-Go nabs preferred status on OptumRx formularies
Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device, V-Go, won preferred status on the OptumRx formulary. The Bridgewater, N.J.-based company’s device is designed for people with Type 2 diabetes. The V-Go product is worn like a patch and delivers a preset basal rate of insulin over the course of 24 hours. The device can […]
Beta Bionics raises $63m for bionic pancreas
Boston-based Beta Bionics said this week that it closed a $63 million Series B round to support the development of its iLet bionic pancreas system for people with Type 1 diabetes. The company’s iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous glucose monitor, […]
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