• St. Jude, Medtronic Win MRI-Compatible FDA Approvals

    The trend toward MRI-compatible implants continues as Medtronic and St. Jude Medical announce FDA approvals for MRI-compatible devices.Marie ThibaultMedtronic racked up another FDA approval for an MRI-compatible cardiac rhythm device while St. Jude Medical also announced agency approval for MR-conditional labeling of a spinal cord stimulation system.The regulatory approvals, both announced November 14, are the latest developments in an industry-wide trend toward MRI-safe implants. In...
  • Brain Implant Lets ALS Patient Communicate

    A paralyzed Dutch physician implanted with Medtronic devices was able to operate a speech computer by imagining using her fingers. Nancy CrottiAn implanted brain-computer interface that utilizes Medtronic components has allowed a paralyzed woman to communicate using only her thoughts.Researchers in the Netherlands implanted deep-brain stimulation components made by Medtronic in a 58-year-old internist and late-stage ALS patient Hanneke De Bruijne, MD, in October 2015. Until receiving...
  • 3-D Printed Brain Models Could Improve Surgery

    Researchers aim to improve patient outcomes during neurological surgery through the use of 3-D printing brain models. Kristopher Sturgis3-D printing techniques continue to carve out a space in various realms of the medtech arena, and they soon could have a significant impact on neurosurgery thanks to the joint efforts of St. Louis University and the Walter E. Dandy Neurological Society. Their recent study explores the process of 3-D printing precise replicas of patients’ brains to provide...
  • Medtronic Makes a Big Bundled Ortho Payments Play

    The medtech giant has launched a new orthopedics business centering on Medtronic Orthopedic Solutions, which includes a host of offerings meant to help health providers drive outcomes.Chris NewmarkerMedtronic on Thursday announced the launch of its Orthopedic Solutions Business, a Total Knee Arthroplasty System, and a Medtronic Orthopedic Solutions package meant to help health providers succeed under the new bundled payment models being rolled out by both public and private health insurers...
  • Medtech Insiders Think Trump Is Good

    Or that’s at least the case with many Qmed readers.Chris NewmarkerUpdated November 11, 2016Many of Qmed’s medical device engineering and design readers—nearly 46% to be exact—think U.S. President-elect Donald Trump will be good for the medical device industry, according to a recent readership survey.Predictions about what Trump will do include everything from repeal of the Affordable Care Act to the medical device tax being dead for good. Here’s the full breakdown of the survey:I think...
  • Will President Trump Make Medtech Great Again?

    Here's what the incoming administration of Donald J. Trump could have in store for the medical technology industry.Qmed StaffTrumpBallots have been cast and counted, victory and concession speeches have been made, and Donald J. Trump will be sworn in as president of the United States on January 20, 2017. What might the incoming Trump administration have in store for medtech?Here are a few predictions rounded up by Marie Thibault, managing editor of Qmed sister site MD+DI:Obamacare Could Be...
  • Walgreens Sues Theranos for Millions

    The drugstore chain has sued the Silicon Valley–based blood testing company in order to recover the millions of dollars it invested in the company.Chris NewmarkerWalgreen Co. apparently wants to get back the money it invested in Theranos, suing the once-darling blood testing company in U.S. District Court in Delaware.The complaint itself is sealed, but The Wall Street Journal reports that Walgreens is seeking $140 million—the amount it invested in Theranos.Theranos tells media outlets that it...
  • How Driverless Scooters Could Boost Healthcare

    Advanced software algorithms guide the autonomous vehicle, which could have applications in hospitals, retirement homes, and elsewhere.Maureen KingsleyThe latest entry to the growing fleet of driverless vehicles is the autonomous mobility scooter, developed jointly by MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL), the National University of Singapore, and the Singapore-MIT Alliance for Research and Technology (SMART).Designed with the same sensor configuration and...
  • Bionic Eyes Are Getting Even Better

    French medtech firm Pixium announces the first successful implantation of its 150-electrode bionic vision system, with the person receiving the implant reporting that he can see light again.Nancy CrottiA retinitis pigmentosa patient in London was the first to receive Pixium Vision’s Iris II, a 150-electrode, bionic vision system, according to the company.The system contains a bio-inspired camera and a 150-electrode epiretinal implant that is designed to be explantable. The camera’s action is...
  • Philips Settles Patent Case for $300 Million

    The settlement ends seven years of patent litigation with Masimo and actually marks the beginning of a business partnership.Nancy CrottiRoyal Philips has agreed to pay Irvine, CA–based Masimo Corp. $300 million to settle a patent infringement case.The settlement also includes an agreement for the two companies to form a wide-ranging, multi-year business partnership involving both companies’ innovations in patient monitoring and therapy solutions. A Masimo SEC filing spells out the terms of the...
  • 10 Medtech Hazards You Need to Avoid

    The ECRI Institute has released its list of the top 10 health technology hazards for 2017.Marie ThibaultHere’s one ranking of medical technologies won’t want to make.The ECRI Institute has published its annual list of the Top 10 Health Technology Hazards, and infusion errors are the number one concern for 2017. According to the group’s report, the potential for errors and safety mechanism failures with infusion pumps is a major cause for concern, given the potential for serious harm or...
  • Is Boston Sci's Synergy Stent Worth the Price?

    One-year results from a clinical trial comparing drug-eluting stents from the company and two of its competitors suggest maybe not.Maureen KingsleyOne-year results are in for the ongoing large-scale, Netherlands-based Bio-Resort clinical study comparing the safety and effectiveness of three big-name drug-eluting stents head to head.To Medtronic’s delight, after one year its conventional durable-polymer  Resolute Integrity stent demonstrated results equal to those of Boston Scientific’s...
  • These Stuffed Animals Have Device Design Lessons

    It’s one thing to give stuffed animals to Alzheimer’s and dementia patients who need soothing. It’s another thing to design “smart” stuffed animals with therapeutic capabilities.Kristopher SturgisFiona Kalensky holds one of the Therapalz (Image courtesy of University of Illinois Engineering)What could be so complicated about a stuffed animal that provides comfort for patients suffering from Alzheimer’s and dementia? It’s actually more complex than you might think.Just ask University of...
  • How a Flat Tire Inspired a Breast Device

    AirXpanders is touted as a less painful alternative to saline shots for mastectomy patients.  Nancy CrottiUpdated November 4, 2016It all started with a flat tire. San Jose, CA, plastic surgeon Daniel Jacobs pulled out a carbon dioxide cartridge to fill a bicycle tire and began to wonder if he could use the same technology in a breast tissue expander.Eleven years later, the company built from that idea has completed a pivotal trial and is awaiting a 510(k) decision from FDA. AirXpanders...
  • More Patient Deaths Linked to Medtronic Infusion Pump

    Medtronic’s SynchroMed II Implantable Drug Infusion Pump has been tied to two more deaths, according to a letter from the company. Qmed Staff A Medtronic implantable infusion pump that has already been blamed for 14 deaths, cited in several Class I recalls, and which was hit last year with an FDA consent decree is now being tied to two additional deaths, according to a letter from the company.The SynchroMed II Implantable Drug Infusion Pump can cause “delivery of more drug volume than the...
  • Medtech Funnelling Money into Minnesota Congressional Races

    Races involving a former St. Jude Medical exec and a stalwart industry champion have drawn a wealth of political contributions from the medtech industry.Nancy CrottiWith Election Day just days away, the medtech industry continues to focus its money and attention on two Minnesota congressional races.After Democratic presidential candidate Hillary Clinton, the top two recipients of donations from the medical supply industry (which includes medtech) were Angie Craig, a Democrat and former St. Jude...
  • New Color Format Could Boost Ultrasound

    University of Rochester researchers have incorporated new color identifications to ultrasound images, providing clarity to previously indistinguishable objects.Kristopher SturgisA new imaging format for ultrasound machines uses a set of mathematical functions to integrate color identifications so that doctors differentiate between muscle, veins, arteries, and other soft tissue, according to the University of Rochester researchers who created the new format.The new format could represent an...
  • Stents Could Be As Good As Coronary Bypass Surgery

    The findings come from an international study involving 1905 patients with left main coronary artery disease.Nancy CrottiA new international study has found that drug-eluting stents are as effective as surgery for many patients with a blockage in the left main coronary artery.In the study, 1905 patients with left main coronary artery disease (LMCAD) and low or intermediate coronary artery disease complexity were randomized to receive bypass surgery or Abbott’s Xience drug-eluting stent, which...
  • New Patch Shows Promise Against Peanut Allergies

    The patch, which seems particularly effective in young children, “trains” the immune system to tolerate higher doses of peanut protein with no reported major side effects.Maureen KingsleyAn ongoing clinical trial of a wearable skin patch to treat life-threatening peanut allergy is looking promising at the one-year mark, particularly for young children, according to results published online on October 26 in the Journal of Allergy and Clinical Immunology.The Phase II trial, sponsored by the...
  • The Promise of Exoskeletons

    ReWalk’s robotic exoskeleton transformed the life of architect Robert Woo, who was paralyzed from the chest down after a construction accident. Qmed StaffHow much could robotic exoskeletons better the lives of people with paralyzed legs? There's a great example to be had in one of the latest episodes of Freethink Media's Superhuman series. (Check out other episodes here.) Finding out about ReWalk's robotic exoskeleton was a "glimmer of hope" for Robert Woo, an architect in...