Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. […]
Regulatory/Compliance
EMA gives positive opinion on Novo Nordisk’s human insulin with flexible storage
Novo Nordisk (NYSE:NVO) announced that the European Medicines Agency (EMA) granted a positive opinion on a storage update for insulin. EMA’s positive opinion relates to a proposed update to the storage conditions of two human insulins: Actrapid (short-acting insulin) and Insulatard (intermediate-acting insulin). Bagsværd, Denmark-based Novo Nordisk said in a news release that the EMA’s […]
FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic
Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate. Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. Get the full story at our […]
GE Healthcare wins FDA premarket approval for software used in anesthesia delivery system
GE Healthcare (NYSE:GE) announced today that the FDA granted premarket approval for its End-tidal (Et) control software in anesthesia delivery. Approval covers the use of the Et control software for general anesthesia delivery on GE Healthcare’s Aisys CS2 anesthesia delivery system. The technology was released in Europe in 2010 and today can be used to […]
FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients
Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform. Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet […]
Japan approves expanded reimbursement coverage for Abbott’s FreeStyle Libre CGM
Abbott (NYSE:ABT) announced today that it received expanded reimbursement coverage in Japan for the FreeStyle Libre system. Japan’s Ministry of Health, Labour and Welfare approved the expansion for the continuous glucose monitoring (CGM) system to include all people with diabetes who use insulin at least once per day. Abbott Park, Illinois-based Abbott said the expanded […]
Boston Scientific warns on some SpaceOAR systems
Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced […]
Johnson & Johnson is bringing the world’s first drug-eluting contact lens to market
Johnson & Johnson has a potential alternative to eye drops with its drug-eluting Acuvue Theravision contact lens. As far back as the early 1960s, researchers toyed with the idea of delivering medication through contact lenses. Johnson & Johnson Vision (NYSE:JNJ) Director of Clinical Science Dr. Brian Pall told Drug Delivery Business News that patents back then […]
Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol
Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort. In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for […]
FDA clears Fresenius Kabi wireless Agilia Connect infusion system
Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion system. Lake Zurich, Illinois-based Fresenius Kabi’s Agilia Connect infusion system includes the Agilia volumetric pump and the Agilia syringe pump with Vigilant software suite-Vigilant Master Med technology. According to a news release, the two pumps are the first to […]
