Arecor Therapeutics plc has presented early stage clinical data from a novel concentrated insulin formulation, which it hopes will outperform marketed rivals by allowing lower volume and reduced frequency doses. Cambridge, U.K.-based Arecor presented data at the International Advanced Technologies and Treatments for Diabetes meeting from AT-278, an investigational meal-time concentrated (500 U/mL) novel formulation of insulin.
Ascensia Diabetes Care Holdings AG aims to reduce the pain associated with continuous glucose monitoring (CGM) just a bit with a new cost structure for Senseonics Holdings Inc.’ Eversense E3 CGM. The system, which lasts a ground-breaking six months without replacement, received FDA clearance in February.
A smart contacts lens that detects diabetes and treats diabetic retinopathy could provide patients with a more comfortable alternative to insulin shots and monitoring blood glucose levels. The product was developed by a research team at the Pohang University of Science & Technology (POSTECH) that includes Sei Kwang Hahn, the CEO of Seoul, South Korea-based Phi Biomed Co. Ltd.
The C-suite at Dexcom Inc. is breathing easy with the company having snagged CE marking for its latest continuous glucose monitoring (CGM) system, the G7, less than two weeks after receiving FDA breakthrough device designation for its CGM for hospital use. “This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better,” said Dexcom CEO Kevin Sayer.
A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.
At long last, the FDA granted premarket approval to Senseonics Holdings Inc.’s fully implantable Eversense E3 continuous glucose monitoring (CGM), an implantable device that provides accurate glucose readings for six months. The CGM will be available in the U.S. through Senseonics’ commercial partner, Ascensia Diabetes Care Holdings AG, starting in the second quarter. In Europe, the previous generation Eversense XL is available today and the company plans to launch the E3 in the third quarter of 2022.
Second Sight Medical Products Inc. has struck a deal to acquire Nano Precision Medical Inc. (NPM) in an all-stock transaction. NPM will merge with a wholly owned subsidiary of Second Sight, and the combined company will focus on the development of drug and device medical implants. The deal comes less than a year after Second Sight’s proposed acquisition of French company Pixium Vision LLC fell through in controversial fashion. The company will issue approximately 134 million shares of its common stock to acquire full ownership of NPM and shareholders will acquire approximately 23% equity of the combined company
Know Labs Inc. has received approval from an independent institutional review board for an internal clinical study of its noninvasive glucose monitoring technology. The aim is to further validate the Bio-RFID (radio frequency identification) platform’s ability to accurately measure and detect changes in blood glucose levels. The study will be conducted at the Seattle-based company’s new research and development laboratory and include 200 subjects.
Glooko Inc. acquired Xbird GmbH to further build out its diabetes management platform by adding Xbird’s just-in-time artificial intelligence (JITAI) system to provide adaptive interventions that can enable better informed decision making in the moment. The company declined to provide details of the transaction.
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.