The FDA has granted Beta Bionics breakthrough device designation for its iLet bionic pancreas system. The designation provides Beta Bionics with priority FDA review. It covers all configurations of the device — insulin-only, glucagon-only, and bi-hormonal, including use with Zealand Pharma’s dasiglucagon, a glucagon analog in a ready-to-use aqueous solution, according to Boston-based Beta Bionics. […]
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) […]
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous […]
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 […]
Beta Bionics raises $58m for iLet bionic pancreas
Beta Bionics has raised $57.5 million from 24 investors to help fund the development of its iLet bionic pancreas, according to a document filed with the SEC this week. The Mass.-based company is offering equity and securities as part of the indefinite round. Beta Bionics’ dual-chamber bionic pancreas is designed to use blood glucose data […]
Beta Bionics taps Senseonics’ implantable glucose monitor for artificial pancreas
Senseonics‘ (NYSE:SENS) said today that it inked a deal to integrate glucose data from its Eversense continuous glucose monitoring system into Beta Bionics‘ investigational iLet bionic pancreas. According to the terms of the development agreement, Beta Bionics and Senseonics will work together to combine the two systems in the hopes of driving insulin and glucagon […]
Beta Bionics wins FDA nod for home-use trial of artificial pancreas tech
Beta Bionics said this week that it won FDA approval to start recruiting patients with Type I diabetes for home-use studies of its iLet bionic pancreas system. The trial is slated to test Novo Nordisk’s fast-acting insulin, Fiasp, with the company’s autonomous infusion pump in adults with Type I diabetes. The study will also evaluate […]
Beta Bionics raises $2m
Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. The company is […]
Artificial pancreas: These companies are racing to make one
Medical device companies are close to achieving the holy grail of diabetes treatment: a combined glucose sensor, control algorithm and insulin infusion device that effectively acts as an “artificial pancreas.” We explain more in the newest video from editors at Drug Delivery Business’s sister publication Medical Design & Outsourcing. (And for a deeper dive, check out […]
Researchers’ bionic pancreas outperforms standard insulin pump therapy
Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet. This device is the latest development in the race to make an entirely closed loop insulin pump system, […]
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