The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes. Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical devices while they are flash-sterilized for immediate use. In its March 20, […]
Abbott’s MitraClip may win expanded Medicare coverage
Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
V-Wave wins breakthrough nod for heart failure device
V-Wave said today that the FDA has granted breakthrough device designation for its interatrial shunt for heart failure (HF). The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced […]
FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. Get the full story on our sister […]
FDA slaps Class I label on Fresenius Kabi USA infusion pump recall
The FDA has designated a recall of Fresenius Kabi USA infusion devices and software as Class I, the most serious type of recall. In June, Fresenius Kabi USA voluntarily began the recall of its Volumat MC Agilia volumetric infusion pump to upgrade an alarm that signals when the infusion is complete, and of its Vigilant […]
Dalent Medical readying to launch Sinusleeve device
Dalent Medical said last week that it has listed its Sinusleeve balloon sinus dilation device with the FDA. Sinusleeve is a single-use, disposable device used for treating chronic sinusitis, according to the Miami-based company. Sinusleeve is an FDA 510(k)-exempt Class 1 device that the company said it will begin marketing immediately to otolaryngologists in Florida. Get […]
Massive Teleflex endotracheal tube recall extends to Centurion Medical Products
A Class I recall of 6 million Teleflex (NYSE:TFX) Sheridan endotracheal tubes and connectors indicated for use on patients under general anesthesia has expanded to include connector kits manufactured by Centurion Medical Products, according to the FDA. Teleflex began recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes in June 2019 due to complaints of the Sheridan […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
BD beats Wall Street on Q3 earnings, reveals FDA denial of Lutonix PMA for PAD
This article has been updated to include information from the company’s earnings call with analysts. Becton Dickinson & Co. (NYSE:BDX) posted third-quarter results today that beat the consensus earnings forecast on Wall Street and maintained its FY2019 guidance, citing strong year-to-date results and continued momentum. On the downside, CEO Vincent Forlenza told analysts that the […]
FDA slaps Abbott ICD recall with Class I label
The FDA has labeled a recent Abbott (NYSE:ABT) recall of Ellipse implantable cardioverter defibrillators (ICDs) as the most serious type, which could result in patient death. The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally. Today’s FDA announcement said that a faulty manufacturing process had left the Ellipse […]
These 7 trends matter the most for medtech in 2019
The medical device industry is experiencing another eventful year in 2019. Medtech companies face many headwinds, from the U.S.-China trade war to an FDA under fire. But the industry is also seeing the rise of new technologies — especially robot-assisted surgery. In fact, so many major companies are getting involved in robot-assisted surgery that some […]
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