MannKind (Nasdaq:MNKD) announced today that it received FDA approval for an update to the prescribing information for Afrezza inhaled insulin. Afrezza (insulin human) inhalation powder is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion […]
FDA
Medtronic wins FDA clearance for MiniMed Go app for InPen smart insulin pen
Medtronic (NYSE:MDT) announced today that the FDA granted 510(k) clearance for its MiniMed Go app for multiple daily injections (MDI). MiniMed Go, a smart MDI system, integrates the InPen smart insulin pen with the Instinct sensor made by Abbott. It all integrates within the app to deliver real-time, personalized insights and actionable guidance. Medtronic and […]
Diabeloop wins FDA nod for new automated insulin delivery algorithm
Diabeloop announced today that its DBLG2 algorithm for automated insulin delivery has received FDA 510(k) clearance. DBLG2 received authorization as a Class II interoperable automated glycemic controller (i-AGC). Clearance validates the algorithm’s interoperability and could bring more choice to people with diabetes, the company said on LinkedIn. It marks the latest milestone for the company’s […]
Insulet wins FDA clearance for Omnipod 5 algorithm enhancements
Insulet (Nasdaq:PODD) announced today that it received FDA 510(k) clearance for new enhancements to its Omnipod 5 system. The Acton, Massachusetts–based company said the updates to its tubeless, wearable automated insulin delivery patch pump’s algorithm include a new benchmark in tubeless diabetes technology with a lower, 100 mg/dL target glucose option. It also delivers a […]
FDA accepts MannKind sNDA for autoinjector that treats edema
MannKind (Nasdaq:MNKD) announced that the FDA accepted a supplemental New Drug Application (sNDA) for its Furoscix ReadyFlow autoinjector. The Furoscix ReadyFlow autoinjector (SCP-111) was developed to deliver a subcutaneous furosemide injection as an investigational alternative to the FDA-approved Furoscix on-body infusion device for treating edema in adult patients with chronic heart failure (CHF) or chronic […]
Dexcom wins FDA nod for smart CGM-integrated basal dosing for type 2 diabetes
Dexcom (NSDQ:DXCM) announced today that the FDA cleared its Smart Basal CGM-integrated basal insulin dosing optimizer. The continuous glucose monitor (CGM)-based offering received clearance for adults with type 2 diabetes on glargine U-100 long-acting insulin therapy. San Diego-based Dexcom says it marks the first and only CGM-integrated basal dosing optimizer cleared for type 2 diabetes. […]
Modular Medical submits next-gen insulin pump to FDA, expects 2026 launch
Modular Medical (Nasdaq:MODD) announced that it has submitted its next-generation Pivot insulin pump to the FDA for clearance. Modular Medical’s current pump, the MODD1, won FDA clearance nearly a year ago. It has microfluidics technology that allows for the low-cost pumping of insulin. The company announced earlier this year that it began converting its manufacturing line to […]
FDA accepts application for MannKind inhaled insulin in kids
MannKind (Nasdaq:MNKD) announced today that the FDA accepted a supplemental biologics license for its Afrezza inhaled insulin. The submission, if ultimately approved, would enable MannKind to bring Afrezza to children and adolescents (aged 4-17). Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder […]
BD expands Alaris recall after identifying new potential issue
BD (NYSE:BDX) announced that it expanded its Class I voluntary recall for its Alaris Pump Module model 8100 infusion system. The expansion builds on a voluntary recall expanded earlier this year, informing customers of worst-case performance instances. Under certain cases, the pump, when used with a subset of compatible infusion sets, fails to perform as […]
FDA identifies serious recall for Dexcom CGM mobile apps
The FDA identified a recent recall of smartphone apps for Dexcom (Nasdaq:DXCM) continuous glucose monitors (CGMs) as the most serious type. This recall involves correcting certain devices through a software update. It does not involve removing them from where they are used or sold. Serious recalls can lead to serious injury or death without correction. […]
