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 intraocular pressure (IOP) across all […]
Drug-Device Combinations
Ypsomed increases auto-injector production in Germany
Ypsomed announced today that it opened a new production hall at its German site in Schwerin to increase auto-injector production. The Burgdorf, Switzerland-based company said its expansion enables an increase in production capacity to meet growing global demand. CEO Simon Michel also said the company plans to further expand the plant in the coming years. […]
Glooko announces CEO transition with $100M financing
Glooko announced today that it secured $100 million in a financing round and appointed Mike Alvarez as its new CEO. Russ Johannesson said on LinkedIn that he stepped down from the CEO post at Glooko. He held the corner office for six-and-a-half years as Alvarez now takes over. Alvarez brings more than two decades of […]
Clearside Biomedical’s drug-device combo study meets endpoints
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 the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to […]
Trinity Biotech completes pre-pivotal study of next-gen CGM
Trinity Biotech today announced that it completed the first pre-pivotal clinical trial in Europe for its next-generation CGM technology. The study assessed the analytical performance of continuous glucose monitoring (CGM) technology enhancements implemented by Trinity. Dublin, Ireland-based Trinity added the improvements to the CGM technology it acquired from Waveform Technologies in January. Trinity implemented an […]
Medinol has first human implant of drug-eluting peripheral stent in Australia
Medinol today announced the successful first-in-human implantation of its ChampioNIR drug-eluting peripheral stent. Dr. Gerard S. Goh and Dr. Thodur Vasudevan of the Alfred Hospital in Melbourne, Australia, completed the stent implant. The company says it introduces a “revolutionary advancement” in the mechanics, durability and drug delivery of peripheral drug-eluting stents. Tel Aviv, Israel-based Medinol […]
BD partners with ten23 health on prefilled syringe manufacturing
BD (NYSE:BDX) announced today that it entered into a collaboration with ten23 health to develop a new way to track prefillable syringes (PFS). ten23 health, a Swiss CDMO, offers drug development, filling and device assembly expertise to contribute to the product offering. It recently entered into a production collaboration with on-body drug delivery device maker […]
ApiJect Systems promotes COO from within
Injection delivery system developer ApiJect announced that it promoted Molly Weaver to the position of chief operating officer. Weaver’s background includes both the pharmaceutical and medical technology markets. Her experience spans strategy, product development and execution across a broad range of industrialization and drug delivery systems. Most recently, Weaver served as chief technology officer at ApiJect. […]
Medtronic recalls some MiniMed automated insulin delivery systems with battery issues
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. The medtech giant issued a field action starting on July 31, notifying customers to follow built-in alerts for battery status. Customers should contact Medtronic if […]
Eyenovia begins manufacturing next-gen drug delivery system
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. The company plans to have Mydcombi undergo 12-month […]
