Some patient safety advocates are criticizing U.S. Senator and Democratic presidential contender Amy Klobuchar for favoring medtech companies over consumers, according to a report by the Associated Press and the International Consortium of Investigative Journalists. Klobuchar is in her third term representing Minnesota, one of three major medtech hubs in the United States. The journalism organizations reviewed […]
Masimo wins CE Mark for next-gen SedLine pediatric brain monitor
Masimo (NSDQ:MASI) said today that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients. The Irvine, Calif.-based company said that with the clearance, its next-gen SedLine monitoring tech is now available for all patients one year and older in CE Mark countries. Masimo said that […]
Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell
Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal. The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to […]
FDA warns of potential medical device shortage following Sterigenics plant shutdown
FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be […]
T2 Biosystems wins FDA breakthrough nod for drug resistance blood test
T2 Biosystems (NSDQ:TTOO) said yesterday that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample. The T2Resistance Panel is designed to identify 13 genes that the Lexington, Mass.-based company said include “the most clinically important.” This includes genes that indicate a resistance […]
FDA warns against robot-assisted breast cancer surgeries
FDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer. The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said […]
FDA head Gottlieb promises timely device reviews post-shutdown
Despite a 35-day government shutdown that directly affected its ability to perform, the FDA said that it still plans to hold itself to established timelines for device and drug reviews for the year. In a statement released yesterday to the House Appropriations Subcommittee, FDA Commissioner Dr. Scott Gottlieb acknowledged that during the shutdown the agency […]
Robocath wins CE Mark for R-One coronary platform
Robocath said today that it won CE Mark approval in the European Union for its R-One cardiovascular-focused robotics system. The Rouen, France-based company touted the R-One as the first interventional cardiology-focused robotic system to win CE Mark approval. The system is designed to assist in stenting procedures, Robocath said. The company said that it is […]
FDA clears Medtronic Accurian RF nerve ablation device
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain. “Medtronic has a long-established track record of bringing to market improved options to support clinicians with state-of-the-art technology, like the Accurian RF ablation system, which was designed for consistency and efficiency,” pain […]
Medtronic wins expanded FDA indication for Resolute DES
Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion. The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said. Read the whole story on our sister site, Drug Delivery […]
FDA clears Mauna Kea Technologies system for lung cancer detection
Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received 510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer. Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment […]
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