Novo Nordisk announced that the FDA issued a Complete Response Letter (CRL) related to its once-weekly insulin submission. In the CRL, the FDA made requests for Novo Nordisk to complete before it can complete its review of a Biologics License Application (BLA). As a result, the insulin maker said it does not expect to fulfill […]
Food & Drug Administration (FDA)
Roche, Genentech to reintroduce drug-eluting eye implant in U.S. following 2022 recall
Roche subsidiary Genentech today reintroduced its Susvimo therapy for delivery via ocular implant in the U.S. following a recall. The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. […]
CeQur wins FDA nod for mealtime insulin delivery device
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 […]
The biggest stories from the American Diabetes Association (ADA) 2024 Scientific Sessions
The American Diabetes Association took to Orlando, Florida, the past few days for its 84th Scientific Sessions as optimism grows over diabetes tech. Topics covered included expanding technologies to the type 2 diabetes population (90% of people with diabetes), GLP-1 drugs, automation, broadening user bases and more. The usual big-hitters stepped up to the plate […]
Sequel Med Tech’s unique twiist automated insulin delivery system brings something new to the space
Sequel Med Tech made significant waves when it announced the receipt of FDA clearance for an automated insulin delivery system in March. The company, founded just last year, brings significant expertise in a number of channels to the table, despite its short history. CEO Dr. Alan Lotvin co-founded Sequel, bringing decades of experience as an […]
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 […]
