The FDA today approved the first medical device to harness artificial intelligence for the detection of diabetic retinopathy in adults who have diabetes. IDx’s software uses an algorithm to analyze images of the eye taken with a retinal camera. A doctor uploads the images to a cloud server with IDx-DR software, which then tells the […]
Diabetes
Tandem inks distro deal in Italy for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) has signed a distribution deal with Movi SpA to commercialize Tandem’s t:slim X2 insulin pump in Italy. The San Diego, Calif.-based company said today that Movi is slated to run sales, marketing and customer training for Tandem’s products in Italy, according to the terms of the agreement. “Partnering with experienced insulin pump […]
Ascensia looks to expand access to blood glucose monitoring tech for UnitedHealthcare enrollees
Ascensia Diabetes Care inked a new relationship with UnitedHealthcare (NYSE:UNH), the company touted today, which is designed to improve access to Ascensia’s Contour Next blood glucose meters and test strips for UnitedHealthcare members. Now, people enrolled in UnitedHealthcare’s employer or commercial plans can get a meter or test trip through their pharmacy benefit at a Tier 2 […]
Eli Lilly inks $63m deal with Sigilon to develop encapsulated cell therapies for diabetes
Eli Lilly (NYSE:LLY) plans to put $473 million on the table to fund a collaboration with Cambridge, Mass.-based startup Sigilon Therapeutics, the insulin-maker reported today. The goal of the newly-established partnership is to develop encapsulated cell therapies to treat Type I diabetes. In patients who suffer from Type I diabetes, pancreatic beta cells are killed off […]
AstraZeneca’s once-weekly diabetes drug wins expanded FDA approval
AstraZeneca (NYSE:AZN) said today that the FDA approved its extended-release formulation of exenatide, Bydureon, for use as an add-on therapy to basal insulin in adults with Type II diabetes. The company’s once-weekly GLP-1 injectable was first approved in the U.S. in 2012. Bydureon’s expanded use is based on data from AstraZeneca’s 28-week Duration-7 trial, the company […]
Dexcom CEO on ‘treading new ground’ with G6 glucose monitor
Kevin Sayer sold his first glucose sensor in 1994. More than twenty years later, the chief executive of Dexcom (NSDQ:DXCM) still believes that glucose-monitoring technology can transform the way patients manage their diabetes. This week, Dexcom won FDA approval for its latest continuous glucose monitor. The G6 system is the first of the company’s that does […]
FDA committee backs Senseonics’ implantable continuous glucose monitor
An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week. The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective. The company’s […]
Bigfoot brings Series B total to $55m with new investment from Abbott
Reeling in an $18 million add-on to the $37 million Series B that it reported last year, Bigfoot Biomedical touted today that it has raised over $90 million in total funding since the Milpitas, Calif.-based company first launched. Investments from Abbott (NYSE:ABT), which has an established partnership with Bigfoot, and other new and existing investors, brought the […]
EU, Australia approve insulin glargine biosimilar
Mylan (NSDQ:MYL) and Biocon touted today that Semglee, their co-developed insulin glargine biosimilar, won approval in the European Union and in Australia. The product will be sold in a pre-filled disposable pen and is the first biosimilar from Biocon and Mylan to be cleared in Europe. Semglee will launch in Australia later this year, Mylan reported, […]
Dexcom wins FDA nod for first interoperable continuous glucose monitor
Dexcom (NSDQ:DXCM) shares jumped yesterday after the company scored a unique FDA approval for its G6 continuous glucose monitor, marking the first time the U.S. regulatory agency has cleared a CGM as “fully interoperable” with other medical devices. The company’s latest CGM also eliminates the need for patients to calibrate the device by pricking their fingers. […]