Researchers at McMaster University in Canada announced that they received $8.2 million from the Canadian Institutes of Health Research (CIHR). Fiona Smaill picked up $8.2 million to advance an inhaled COVID-19 vaccine through to Phase 2 human trials. The trials will evaluate the safety and immunogenicity of the next-generation vaccine delivered by inhaled aerosol. Her […]
CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device
CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy device. Milford, Massachusetts-based CardioRenal Systems designed the device for preventing acute kidney injury (AKI). It’s for patients at risk for cardiac surgery-associated AKI. RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration. It […]
Akili lays off 46 workers
Akili announced that its board of directors approved an operating plan for 2023 that includes a 30% workforce reduction. The Boston-based digital therapeutic developer’s reduction reaches across different areas and functions. In total, 30% of Akili’s workforce amounts to 46 employees. The company communicated the decision to employees on Jan. 12 and expects to complete […]
Eitan Medical opens new manufacturing facility for wearable drug delivery platform
Eitan Medical announced today that it opened a new manufacturing facility at its headquarters to support drug delivery device production. Netanya, Israel-based Eitan intends for the facility to manufacture its Sorrel wearable drug delivery platform. That includes multiple device configurations, such as vial- and cartridge-based wearable injectors. On-site manufacturing supports Eitan’s production scale for its […]
How Dexcom aims to extend its mission beyond diabetes
CEO Kevin Sayer explains how, following the launch of the next-generation Dexcom G7, the company is looking toward the future. Dexcom (Nasdaq:DXCM) ended 2022 strong, receiving FDA clearance for its next-generation G7 continuous glucose monitor (CGM). With a U.S. launch imminent, the company could keep its efforts centered on the diabetes space. Instead, the company […]
Oramed may discontinue oral insulin activity for type 2 diabetes after trial misses endpoints
Oramed Pharmaceuticals (Nasdaq:ORMP) announced that top-line Phase 3 trial results for its oral insulin candidate missed its endpoints. The Phase 3, randomized, double-blind, placebo-controlled trial compared the efficacy of ORMD-0801 to placebo. It evaluated patients with type 2 diabetes at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control. Those patients were […]
Diabeloop, EOFlow partner on wearable automated insulin delivery in Europe
Diabeloop and EOFlow announced that they partnered to offer the latter’s EOPatch system with automated insulin delivery in Europe. This partnership combines the EOPatch, a third-party continuous glucose monitor (CGM) and Diabeloop’s automated insulin delivery algorithm. They all integrate into Diabeloop’s currently under-development smartphone app. Paris-based Diabeloop said in a news release that they also […]
This AI-based smartphone app helps diabetes patients manage blood sugar
Oregon Health & Science University (OHSU) combined AI and diabetes experts to develop a smartphone app to help manage blood sugar levels. OHSU biomedical engineer Peter Jacobs and OHSU endocrinologist Dr. Leah Wilson lead this project. They plan to organize a randomized clinical trial to evaluate an enhanced app used in concert with diabetes education […]
Vero Biotech raises $30M for tankless nitric oxide delivery system
Vero Biotech announced today that it raised $30 million to support its Genosyl inhaled nitric oxide (iNO) delivery system. The financing comes just days after the company received FDA approval for Genosyl. The third-generation Genosyl delivery system features faster dosing, simpler workflow and operational efficiency. Petrichor, a healthcare-dedicated growth capital provider, led the financing. Atlanta-based […]
Tandem Diabetes Care expects double-digit revenue growth in 2023
Tandem Diabetes Care (Nasdaq:TNDM) announced preliminary fourth-quarter results and offered expectations for the coming year. San Diego-based Tandem expects sales to total $221 million, coming in $11 million higher than the same quarter last year. Wall Street analysts expected $221.6 million in revenues. However, the automated insulin delivery technology developer noted that its adjusted sales […]
