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 […]
Regulatory/Compliance
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 […]
Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott (NYSE: ABT) has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable. The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more […]
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 […]
Recall of Tandem Diabetes Care insulin pump app software is Class I, more than 200 injuries reported
The FDA labeled a recall of a Tandem Diabetes Care (Nasdaq:TNDM) automated insulin delivery app’s software Class I, the most serious kind. This recall constitutes a correction, not a product removal. Tandem recalled Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology. It initiated […]
