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 […]
Food & Drug Administration (FDA)
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 […]
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 […]
Senseonics posts Q1 sales beat, submits 365-day iCGM to FDA
Senseonics (NYSE:SENS) shares ticked up after the market closed today on first-quarter results that came in ahead of the consensus sales forecast. Shares of SENS rose 8.1% to 41¢ apiece in post-market trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down slightly. […]
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 […]
