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 […]
Food & Drug Administration (FDA)
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 […]
FDA clears Dexcom G7 next-gen CGM
Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system. FDA clearance for the highly anticipated device covers people with all types of diabetes aged 2 years and older. San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute […]
FDA clears Mallya smart insulin pen device from Biocorp
Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical device that connects insulin pens. Mallya, a smart sensor, attaches directly to insulin pen injectors to make them connected devices. It automatically collects nad records key treatment information and transmits it to a dedicated digital application. That data includes selected […]
Better Therapeutics submits FDA de novo request for type 2 diabetes treatment
Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the FDA for its BT-001 technology. San Francisco-based Better Therapeutics seeks marketing authorization for the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. Marketing initially would cover type […]
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]
Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump
Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with some MiniMed automated insulin delivery systems. The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose […]
Advanced NanoTherapies wins FDA breakthrough nod for drug-coated balloon
Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB). Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo […]
Recall of Baxter Clearlink due to risk of leaks is Class I
The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy […]
