CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for the wearable mealtime insulin delivery patch from three to four days. It marks a significant advancement for what the company says is the longest wearable insulin delivery patch, which provides diabetes […]
Regulatory/Compliance
Senseonics expects a Q4 launch for 365-day CGM, offers full-year outlook
Senseonics (NYSE:SENS) today shared its full-year financial outlook and laid out expectations for a new product launch this year. The Germantown, Maryland-based company said the FDA review of its next-generation, 365-day, once-per-week calibration Eversense implantable continuous glucose monitor (CGM) is advancing as planned. It expects the progress to enable 510(k) clearance in the near future […]
Insulet seeks expanded FDA nod for Omnipod 5 to include type 2 population, reports positive data
Insulet (Nasdaq:PODD) today announced positive results from a type 2 diabetes pivotal trial of its Omnipod 5 automated insulin delivery system. The company recently submitted its study results to the FDA for an expansion of Omnipod 5’s indications for use. It hopes to garner clearance for the type 2 diabetes population and launch in the […]
Elixir Medical wins FDA breakthrough nod for sirolimus-eluting bioadaptor system
Elixir Medical announced today that it received FDA breakthrough device designation for its DynamX bioadaptive implant. The breakthrough nod covers the improvement of coronary luminal diameter, restoration of hemodynamic modulation and reduction of plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. It follows a March […]
Merit Medical recalls certain products containing syringes made in China
Merit Medical issued an urgent medical device recall notice related to specific products that contain plastic syringes made in China. Certain lots of Merit products contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Merit received notice from its supplier indicating that it supplied the company with those syringes. All but one size/type of […]
FDA says Vivani Medical can begin study of long-term GLP-1-eluting implant
Vivani Medical (Nasdaq:VANI) announced today that the FDA approved an investigational new drug (IND) application for its long-term GLP-1 implant. The FDA lifted the clinical hold on Vivani’s NPM-119, allowing the initiation of its LIBERATE-1 Phase 1 clinical trial. This trial looks at the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the company’s miniature, six-month […]
Abbott wins FDA clearance for duo of over-the-counter CGMs
Abbott (NYSE:ABT) today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio. The company built both systems on its FreeStyle Libre CGM technology, but both aim to meet different needs. Lingo offers consumers a solution to better understand and improve their health and wellness. Libre Rio provides monitoring for […]
FDA clears portable blood, IV fluid warmer from Mequ
Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform. The Copenhagen, Denmark–based medtech company offers the warmer for both military and civilian use. It features a portable, user-friendly design that enables the warming of blood and IV fluids regardless of location. That […]
Roche warns of software issues for its diabetes care platform
Roche Diabetes Care notified customers of a software bug that could lead to patient data mismatches on its RocheDiabetes Care platform. The RocheDiabetes Care platform offers a browser-based solution for visualizing and analyzing relevant therapy information. That could include glucose values, insulin, nutrition and activity data, helping to make treatment decisions for patients with diabetes. […]
Medline plastic syringe recall expands
The FDA says Medline initiated additional recalls as the company grapples with issues surrounding syringes made in China. Medline’s latest recalls aim to stop using affected products that include bulk unauthorized plastic syringes made in China and bulk plastic syringes made in China with performance testing failures. These add to last month’s recalls asking customers […]
