LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD). For CLTI patients who have lost blood flow below their knee and have no other suitable endovascular or surgical treatment options available, the LimFlow System … [Read more...] about How LimFlow’s foot-saving system prevents amputations in patients with no other options
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Two-armed surgical robot prototype targets pediatric brain tumors
Researchers say they've developed a surgical robot for removing brain tumors in children, and that it could also offer a less invasive, safer option for adult neurosurgery and other procedures. The trick is using hollow, nitinol robot arms to allow neurosurgeons to swap tools during a tumor resection procedure, said Pierre DuPont. He's the chief … [Read more...] about Two-armed surgical robot prototype targets pediatric brain tumors
Zeus opens Minnesota catheter manufacturing facility
Zeus has opened its catheter manufacturing facility in Arden Hills, Minnesota, celebrating the new facility with a grand opening. The 75,600-ft² building is home to CathX Medical, which Zeus acquired 2021. The facility has advanced R&D lab and cleanroom space for designing, developing and validating medical catheter prototypes. The … [Read more...] about Zeus opens Minnesota catheter manufacturing facility
Medical nitinol processing: How NiTi is turned into wire, tubes and sheets for medical devices
Medical nitinol processing transforms raw nickel-titanium alloy into wire, coils, tubes and sheets for medical and dental device manufacturers. We previously covered nitinol's journey from the earth's crust through high-temperature melting crucibles and forging operations to create nitinol ingots and then smaller, more workable shapes such as … [Read more...] about Medical nitinol processing: How NiTi is turned into wire, tubes and sheets for medical devices
J&J used RWE for expanded indications — and you can, too
Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions. Real-world evidence (RWE) took a big step forward recently when the FDA approved expanded indications for Johnson & Johnson MedTech ablation catheters. For the first time, the federal medical device safety regulator … [Read more...] about J&J used RWE for expanded indications — and you can, too
Some hospitalized patients’ infections may develop from their own bacteria in catheters
Researchers in Missouri discovered evidence of infections forming from hospitalized patients' own bacteria in catheters. Studying mice, researchers at Washington University School of Medicine in St. Louis discovered that urinary tract infections (UTIs) can arise after sterile catheter tube insertion into the urinary tract. This can occur even … [Read more...] about Some hospitalized patients’ infections may develop from their own bacteria in catheters
FDA warns of potential toxic risk from Fresenius hemodialysis machines
The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL … [Read more...] about FDA warns of potential toxic risk from Fresenius hemodialysis machines
FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced … [Read more...] about FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes
CoreMap raises $23 million to fund AFib mapping development
CoreMap today announced it closed a $20 million Series B financing to accelerate the development of its cardiac arrhythmia diagnostic technology and launch pilot studies. The Burlington, Vermont–based company said it also closed on a $3 million Series A Milestone financing that was part of its $10.5 million Series A in September 2020. In … [Read more...] about CoreMap raises $23 million to fund AFib mapping development
‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time
After years of development, University of Arizona researchers have captured their first images inside fallopian tubes with a new device that could be used to search for early signs of ovarian cancer. University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 … [Read more...] about ‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time
