Senseonics (NYSE:SENS) announced yesterday that real-world data from its Eversense continuous glucose monitoring system reflected strong performance and safety. The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period. Zero device or procedure-related adverse events were reported with the […]
FDA wants more on new manufacturing process from Clearside Biomedical
Clearside Biomedical (NSDQ:CLSD) said today that the FDA ordered the company to provide stability data on its new manufacturing process for triamcinolone acetonide suspension, pushing the timeline on the agency’s decision into next year. Alpharetta, Ga.-based Clearside’s Xipere device is a suprachoroidal injection designed for the treatment of macular edema associated with uveitis. Clearside said […]
Medtronic wins FDA approval for new extended-wear infusion set
Medtronic (NYSE:MDT) said it earned investigational approval from the FDA to proceed with a trial for a new extended-wear infusion set. The goal of the study is to collect clinical data that supports the use of the device for up to seven days, more than twice the amount of time any infusion set can currently […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
FDA approves delivery system for Intersect ENT’s Propel implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for a new delivery system for its Propel Mini steroid-eluting sinus implant. The Menlo Park, Calif.-based company said the straight delivery system is designed to place the mometasone furoate-eluting Propel Mini in the ethmoid sinus behind the nasal bridge. The SDS is slated to hit […]
Eli Lilly, Aptar win FDA approval for nasal glucagon powder
Eli Lilly (NYSE:LLY) and AptarGroup (NYSE:ATR) today won FDA approval for the first injection-free glucagon for treating severe low blood sugar in diabetes patients. The federal safety watchdog’s approval, of Lilly’s Baqsimi nasal powder and the delivery device developed by Aptar for treating severe hypoglycemia, was based on two studies comparing a single dose of Baqsimi […]
FDA issues new postmarket guidance for drug-device products
The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
Medtronic bids for expanded FDA indication for Guardian Sensor 3
Medtronic (NYSE:MDT) said it asked the FDA for an expanded indication for its Guardian Sensor 3 device that would open the glucose sensor up for Medicare reimbursement. The Fridley, Minn.-based medtech titan said it filed for pre-market approval of non-adjunctive labeling for Guardian Sensor 3 for use with its MiniMed 670G insulin management system. If […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
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