PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. This encompassed the entire process of design, development, manufacturing and distribution for insulin infusion pumps and accessories. Niia Essential, the first of three […]
Business/Financial News
The 10 biggest diabetes tech stories from 2023
It was another banner year for diabetes technology, with regulatory approvals, product launches and M&A all playing their part. Diabetes technology’s impressive 12 months marked a major trend across medtech as a whole, too. In 2022, the diabetes space saw plenty of progress from some of its biggest names and this past year proved no […]
BD inks $85M settlement over Alaris defect disclosure claims
BD (NYSE:BDX) announced that it filed settlement documents for an $85 million agreement to resolve claims regarding its Alaris infusion pump technology. The Alaris system has been much maligned over the past few years. Its troubles date back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software […]
Insulet applauds NICE guidance on hybrid closed loop insulin delivery
Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose […]
Embecta CEO sees GLP-1 opportunities as company progresses on insulin patch pump
Embecta (Nasdaq:EMBC) CEO Dev Kurdikar says the company set out for its second full year since spinning off from BD with three clear goals. The company wanted to keep the core business strong, continue progressing on the separation and standing on its own and, finally, continue investing in growth — namely on its insulin patch […]
Elutia submits drug-eluting biomatrix for use with cardiac implants to FDA
Elutia (Nasdaq:ELUT) announced today that it submitted a 510(k) premarket notification to the FDA for its drug-eluting biomatrix. The company designed its next-generation CanGarooRM for use with cardiac implantable electronic devices like pacemakers and defibrillators. A bioenvelope, CanGarooRM stabilizes the implantable devices. Made from a natural biomaterial that promotes a regenerative healing response, the biomatrix […]
B. Braun launches luer device for IV infusions
B. Braun Medical announced that it launched its new CareSite Micro luer access device designed to make IV access safer. Bethlehem, Pennsylvania-based B. Braun designed the device to reduce exposure to harmful chemicals. It aims to decrease infection risk in IV access for patients and healthcare providers. The company says its device is the only […]
Fresenius Kabi, Mayo Clinic ink deal on Ivenix infusion system
Fresenius Kabi announced that it signed a multi-year purchase agreement with Mayo Clinic centered around large-volume infusion pumps. The Lake Zurich, Illinois-based company expects Mayo Clinic to purchase 10,000 Ivenix pumps for hospitals and clinics in Minnesota, Arizona and Florida. It marks the largest contract for Ivenix pumps signed by the company to date. Ivenix, […]
FDA approves Glaukos iDose TR glaucoma-treating drug delivery implant
Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant. The approval allows for one administration per eye of iDose TR (travoprost intracameral implant) 75 mcg. The indication for the prostaglandin analog covers the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle […]
Encellin closes $9.9M financing to support implantable drug delivery pouch
Encellin announced today that it closed a $9.9 million financing round to support its cell encapsulation platform. The San Francisco-based company develops an encapsulated cell replacement therapy (EnCRT). It isolates therapeutic cells from the body’s immune system to help therapeutic cells survive in the body. Once implanted, cells within the EnCRT can exchange biomolecules with […]