Medtronic (NYSE:MDT) announced today that it received FDA approval for its Simplera continuous glucose monitor (CGM). It marks another boost for Medtronic’s CGM portfolio, which will also include an integrated CGM offering through a collaboration with Abbott announced today. Simplera, the company’s first disposable, all-in-one CGM, comes in at half the size of previous Medtronic […]
FDA
FDA says Alcyone Therapeutics can continue study of drug delivery implant
Alcyone Therapeutics announced today that the FDA approved continued enrollment in a study of its ThecaFlex DRx drug delivery system. The company can continue enrolling in the PIERRE FDA investigational device exemption study for the implantable medical device. It evaluates the system, comprised of a subcutaneous port and intrathecal catheter system. This system provides chronic […]
FDA concerns push Novo Nordisk once-weekly insulin timeline beyond 2024
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 […]
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 […]
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 […]
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 […]
FDA approves hybrid closed-loop insulin delivery app from CamDiab
CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app. CamAPS FX, an Android app, received approval as an interoperable automated glycemic controller device (iAGC). It helps to manage glucose levels in people with type 1 diabetes, aged two and older, including during pregnancy. The app allows […]
FDA warns on more Chinese syringe imports
The FDA added two new China-based companies to its list of syringe manufacturers that can no longer import products to the U.S. In an alert dated May 16, the FDA said Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. failed to meet device quality system requirements. As a result, the two join […]
Carthera wins U.S., EU orphan drug designation for SonoCloud
Carthera announced today that it received FDA and European orphan drug designation (ODD) for the use of carboplatin with its SonoCloud. The designation allows Paris, France-based Carthera to use carboplatin chemotherapy in the treatment of malignant glioma. Carthera conducts this treatment through the use of SonoCloud, a device that emits ultrasound to temporarily increase the […]
