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 […]
Food & Drug Administration (FDA)
Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.
The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable. According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to […]
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 […]
MedAlliance picks up FDA IDE nod for drug-eluting balloon
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 […]
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, […]
FDA clearance for Dexcom G7 marks a ‘huge leap’ forward, COO Jake Leach says
After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here. In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high. About […]
FDA accepts NDA for over-the-counter Narcan nasal spray from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]
