Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Abbott Laboratories Inc. announced U.S. FDA clearance for its next-generation Freestyle Libre 3 continuous glucose monitor (CGM) system for people aged 4 years and older with diabetes. Accuracy of the sensor was evaluated in a non-randomized, multicenter, single-arm study with 100 people on intensive insulin therapy (95, aged 6 years and older). Results from the pivotal trial were released May 31, showing it is the first CGM to demonstrate a mean absolute relative difference (MARD) below 8%, indicating it will be one of the most accurate sensors on the market.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
Evotec AG and Sernova Corp. are joining forces in a bid to develop a functional cure for type 1 diabetes. The companies plan to file an IND early in 2024 for a combined cell therapy and medical device product comprising Evotec’s human beta cells, derived from the company’s induced pluripotent stem cell platform, and Sernova’s Cell Pouch delivery system, which provides transplanted cells with a vascularized, physiologically appropriate environment that enables them to secrete insulin and other hormones involved in regulating blood glucose levels.
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
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.
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