Drug Delivery Business
Sep 6, 2023 · Medtronic recalls some MiniMed automated insulin delivery systems with battery issues. October 4, 2024 By Sean Whooley. Medtronic (NYSE:MDT) today announced a voluntary recall warning of battery issues with its MiniMed 600 and 700 series insulin pumps. FDA deemed the recall Class I, the most serious kind.
FDA approves IDE for Medtronic Prevail drug-coated balloon
1 day ago · Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global ...
Luna launches trial for 'world's smallest insulin patch pump'
1 day ago · October 23, 2024 By Sean Whooley. The Luna platform. [Image from the company’s website] Luna Diabetes announced that it launched its pivotal trial for Luna, the company’s miniature automated insulin delivery system. The company describes the system — designed to transform nighttime glucose management — as the world’s smallest patch pump.
Ypsomed, BD collab on self-injection tech for high-viscosity drugs
1 day ago · The BD Neopak XtraFlow prefillable syringe and Ypsomed YpsoMate auto-injector. [Images courtesy of the companies] BD (NYSE:BDX) and Ypsomed today announced a strategic collaboration to advance self-injection solutions for high-viscosity biologic drugs. In a joint project, the companies pre-assessed and streamlined the integration of the BD Neopak XtraFlow glass prefillable syringe with the ...
SpyGlass shares positive data for drug-eluting intraocular lens
6 days ago · SpyGlass Pharma released 18-month follow-up data highlighting the potential of its intraocular lens (IOL)-based drug delivery platform. Data came from a first-in-human study of 23 patients with glaucoma or ocular hypertension. They received the IOL implant at the time of cataract surgery. The company reported a consistent sustained reduction of ...
Eyenovia begins manufacturing next-gen drug delivery system
Oct 3, 2024 · [Image courtesy of Eyenovia] Eyenovia (Nasdaq:EYEN) announced that it began manufacturing batches of its Mydcombi product for its next-generation delivery platform. Manufacturing registration batches of the FDA-approved Mydcombi mydriasis product marks a key step in the approval process for the company’s state-of-the-art Gen-2 Optejet dispensing platform, according to a news release.
FDA approves next-gen drug delivery system from Medtronic
October 10, 2023 By Sean Whooley. The SynchroMed III system. [Image courtesy of Medtronic] Medtronic (NYSE:MDT) announced today that the FDA approved its next-generation SynchroMed III intrathecal drug delivery system. The medtech giant designed SynchroMed III to treat patients with chronic pain, cancer pain and severe spasticity.
Abbott, Medtronic partner to connect CGM, insulin delivery systems
Aug 7, 2024 · Left: the Abbott FreeStyle Libre 3 CGM. Right: Medtronic’s MiniMed 780G. [Image courtesy of the companies] Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) today announced a global partnership pairing Abbott CGMs with Medtronic insulin delivery systems. The partnership aims to collaborate on a system based on Abbott’s FreeStyle Libre continuous glucose monitors (CGMs) with Medtronic’s ...
Drug-Device Combinations Archives - Drug Delivery Business
October 9, 2024 By Sean Whooley. Clearside Biomedical (Nasdaq:CLSD) today announced that the ODYSSEY study of its drug-device combination achieved its primary and secondary outcomes. Alpharetta, Georgia-based Clearside develops the SCS Microinjector suprachoroidal injection device. It enables an in-office, repeatable, non-surgical procedure for ...
Medtronic pleased with Diabetes unit, FDA's CGM review progress
Aug 22, 2023 · The MiniMed 780G with the Guardian 4 sensor. [Image courtesy of Medtronic] After ending fiscal 2023 on a high, the Diabetes unit at Medtronic (NYSE:MDT) continues to roll on into the company’s new fiscal year. To finish fiscal 2023 (in April), Medtronic received FDA approval for its next-generation MiniMed 780G automated insulin delivery system. . Shortly after, the company fully resolved a ...