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 […]
Food & Drug Administration (FDA)
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 […]
Senseonics wins integrated CGM designation from FDA, can work with insulin pumps
The FDA today granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS). With this designation, Eversense becomes the first fully implantable device in the category. Senseonics can now market the long-term CGM through the FDA’s de novo pathway. This establishes the special controls serving as a predicate device for […]
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott [WtwhTicker symbol=”ABT”](NYSE: ABT)[/WtwhTicker] announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. According to a news release, no stents or drug-coated […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
