Medtronic (NYSE:MDT) said today that the separation of its MiniMed Diabetes unit remains on track as it advances the MiniMed Flex system. On the company’s third-quarter earnings call, CFO Thierry Piéton explained the business’ performance as it works toward completing an IPO — for which it filed at the end of 2025 — and bringing […]
Food & Drug Administration (FDA)
Portal Diabetes earns FDA breakthrough nod for implantable insulin pump
Portal Diabetes announced today that it received FDA breakthrough device designation for its implantable insulin pump system. The Westfield, Indiana–based company can now begin a Phase 1 study to evaluate its proprietary, temperature-stable insulin. It aims to deliver a functional cure for type 1 diabetes. Portal Diabetes developed its system, called the Portal Pump, to […]
Beta Bionics receives FDA warning letter
Beta Bionics (Nasdaq:BBNX) recently disclosed the receipt of a warning letter from the FDA following an inspection. An FDA inspection of the company’s Irvine, California, facility from June 9, 2025, through June 26, 2025, led to the warning letter. In the letter, the FDA outlined deficiencies in the automated insulin delivery system maker’s response letters […]
Abbott receives FDA warning letter related to FreeStyle Libre CGMs
Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre CGM production. The FDA issued the letter on Jan. 23 and made it public today, Feb. 3. It relates to an inspection of Abbott’s Alameda, California, facility from Oct. 14, 2025, through Oct. 23, 2025. According to the […]
Medtronic earns Medicare, FDA wins for MiniMed 780G with Instinct sensor, including for type 2 diabetes
Medtronic (NYSE:MDT) today announced three U.S. milestones expanding access to its MiniMed 780G automated insulin delivery system. The company announced Medicare access for MiniMed 780G paired with the Instinct sensor made by Abbott, FDA clearance for the pairing for insulin-requiring type 2 diabetes and FDA clearance for the system’s use with ultra rapid-acting insulins. Medtronic […]
Glaukos gets FDA nod for iDose TR re-administration
Glaukos (NYSE:GKOS) announced today that the FDA approved a new drug application (NDA) labeling supplement for its iDose TR system. iDose TR (travoprost intracameral implant) offers the reduction of intraocular pressure (IOP). It treats patients with ocular hypertension (OHT) or open-angle glaucoma (OAG). The first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy. It continuously delivers 24/7 therapeutic […]
MannKind earns expanded FDA labeling for inhaled insulin
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 […]
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 […]
MannKind earns FDA nod for on-body infusor, new autoinjector patents
MannKind (Nasdaq:MNKD) announced today that the FDA approved its Furoscix (furosemide) on-body infusor for pediatric patients. The company also received additional IP protection for its investigational Furoscix ReadyFlow autoinjector. ReadyFlow remains under FDA review after the agency accepted a supplemental New Drug Application (sNDA) earlier this month. For the on-body infusor, the FDA approved the […]
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 […]
