MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. […]
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. The system speeds up dosing with an adaptive sensor and automated cassette activation feature. […]
EOFlow submits wearable, disposable insulin patch pump for FDA 510(k) clearance
EOFlow announced recently that it submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. San Jose, California-based EOFlow submitted its application on Dec. 27, 2022. It aims to enter the U.S. diabetes market, expanding its reach outside Korea. The company said in a news release that over 600 people in […]
Beta Bionics appoints new CMO as it prepares for artificial pancreas launch
Beta Bionics announced that it appointed Dr. Steven Russell as its chief medical officer (CMO) as it readies itself for a major product launch. Concord, Massachusetts-based Beta Bionics develops the iLet bionic pancreas system. The pocket-sized, wearable, investigational iLet device autonomously doses insulin. Worn like an insulin pump, iLet users only enter body weight to […]
Dexcom appoints former J&J exec as CCO, sets 2023 guidance
Dexcom (Nasdaq:DXCM) announced today that it appointed Teri Lawver to its newly created role of chief commercial officer (CCO). Lawver’s position oversees the global commercial organization at the continuous glucose monitoring (CGM) technology developer. She holds responsibility for global sales, marketing and customer experience. Before joining San Diego–based Dexcom, Lawver spent two decades in a […]
Sustained Therapeutics advances novel drug delivery platform
Sustained Therapeutics announced that it received regulatory approval in Canada to begin a Phase II trial of its novel pain medication. Vancouver, BC-based Sustained Therapeutics develops a long-lasting non-opioid pain medication. Its trial evaluates a sustained-release platform technology to aid in chronic pain treatment. The company said in a news release that it designed the […]
Know Labs wins new glucose monitoring patent
Know Labs (NYSE:KNW) announced today that it received a new patent equating its diagnostic technology to the current glucose monitoring standard. Seattle-based Know Labs develops the Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. It integrate into wearable, mobile or bench-top form factors. […]
OraMed wins U.S. combination therapy patent for oral GLP-1, insulin
Oramed Pharmaceuticals (Nasdaq:ORMP) announced today that it received a new patent for its oral diabetes treatment. The U.S. Patent and Trademark Office (USPTO) granted a patent titled “Methods and Compositions for Treating Diabetes.” This patent extends a patent previously granted in May 2022. According to a news release, the patent addresses methods and compositions for […]
Ypsomed, Mediq complete sale of DiaExpert
Ypsomed and Mediq announced today that they completed the sale of mail-order retailer for diabetes care DiaExpert. Germany-based DiaExpert specializes in insulin pump therapy. The companies previously announced the sale of DiaExpert in October. This sale allows Ypsomed to focus on the manufacture and sale of its own medical technologies. That focus continues to narrow […]
The 10 biggest diabetes tech stories from 2022
2022 represented a landmark year for next-generation diabetes tech. Here are the biggest stories from the past year. Some companies picked up major regulatory nods. Others experienced major regulatory setbacks. Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from in the world of diabetes tech, […]
