This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical device sterilization plants — […]
Pentax Medical launches Imagina endoscope in U.S.
Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch. The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the […]
Neovasc Reducer gains FDA PMA review
Neovasc this week said it received FDA premarket approval for its Reducer device. Reducer is designed to treat refractory angina, which occurs when the coronary arteries deliver an inadequate supply of blood to the heart. “I would like to reiterate my thanks to the entire Neovasc team for their tireless efforts to complete the submission […]
ArcherDX wins breakthrough nod for personalized cancer monitoring tech
ArcherDX announced that it has won breakthrough device designation from the FDA for its personalized cancer monitoring (PCM) technology. Boulder, Colo.-based ArcherDX’s PCM platform is designed for minimally invasive monitoring and recurrence surveillance for early-stage cancer treatment. It is meant to offer healthcare providers access to genomic information in their laboratory. ArcherDX also recently won […]
TransEnterix wants to use more AI in surgical robotics: Here’s how
TransEnterix (NYSE:TRXC) has filed a 510(k) submission to add an artificial intelligence feature to its robot-assisted surgery system in which the system can automatically move the camera for a surgeon. Surgeons have been able to move the camera on TransEnterix’s Senhance System via eye sensing. But the new Intelligent Surgical Unit would allow a surgeon, for […]
Phagenesis wins FDA breakthrough nod for Phagenyx System for restoring swallowing
Phagenesis announced today that it won breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control. The Phagenyx System is a neurostimulation device designed to use pharyngeal electrical stimulation to treat the cause of dysphagia, accelerating the removal of the breathing tube in the process. Severe dysphagia with related insufficient […]
Staar Surgical wins supplemental lens approval for Evo, Evo+, Visian
Staar Surgical (NSDQ:STAA) announced today that it won CE Mark approval for use of its three ICL lenses as supplemental lenses in post-cataract intraocular lenses surgery patients (pseudophakics). Lake Forest, Calif.-based Staar Surgical’s Evo, Evo+ and Visian lenses all earned the European approval. The Evo/Evo+ and Visian devices are implantable collamer lenses designed to treat myopia […]
Paragonix launches SherpaPak pancreas transport system in U.S.
Paragonix Technologies today announced the FDA clearance and U.S. launch of its SherpaPak pancreas transport system, which the company says is able to provide “unprecedented thermal and physical protection” during the transportation of donor pancreases slated for people with diabetes. “The donor pancreas is highly susceptible to cold and compression injury during transport. Technologies that […]
7 medtech advances to improve diabetes treatment
Medtech and pharmaceutical companies have made several important strides over the past year when it comes to improving diabetes treatment. Multiple treatments and technologies have cleared regulatory hurdles and are now hitting the market and making the process of living with diabetes that much more manageable. Several different styles of therapy and devices have come […]
Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System
Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation. The Temporary Spur Stent system includes radially expandable spikes designed to create multiple pathways for delivering antiproliferative drugs for increased uptake into the vessel wall for facilitating acute luminal gain without leaving anything […]
Medtronic sued over surgical staplers and injury reports
Medtronic (NYSE:MDT) faces lawsuits from three people who claim the company’s surgical staplers seriously injured them — and that the company knowingly sold defective devices and hid the risks, according to a report in the Star Tribune of Minneapolis. Cynthia Nicholson of Harris County, Texas and Robert Snyder of Gilman, Iowa separately sued Medtronic in Hennepin […]
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