MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Abbott wins FDA MR-conditional labeling for Infinity DBS

Abbott wins FDA MR-conditional labeling for Infinity DBS

By

Abbott logo

Abbott (NYSE:ABT) said today it won expanded FDA approval for magnetic resonance conditional labeling for its Infinity Deep Brain Stimulation system designed to treat individuals with Parkinson’s disease and essential tremors.

The update will be delivered through an over-the-air software upgrade to all currently implanted Infinity DBS systems, the company said. Abbott touted that with the approval, the Infinity DBS is the first and only FDA-approved MR-conditional directional DBS system.

“With this software upgrade, Abbott delivers on a promise to develop powerful features that strengthen the Infinity DBS system’s already patient-centric platform, which uses familiar Apple technology and frees the patient from recharging their device. We are committed to continued innovation in neuromodulation, developing ongoing advancements and efficiencies for physicians and, most importantly, helping thousands of people who are battling movement disorders live fuller lives,” Abbott movement disorders medical director Dr. Binith Cheeran said in a press release.

The approval will allow existing implants to be updated via bluetooth with no need for surgery, and allow individuals with the systems to undergo magnetic resonance procedures. The update also includes a number of system upgrades, Abbott said.

“Today’s announcement of the newly released MRI-compatibility of the Infinity DBS system reflects Abbott’s continued commitment to patient-centric, cutting-edge care – where the patient’s options are expanded by the therapy instead of limited by it,” Dr. Brian Kopell of New York City’s Center for Neuromodulation at Mount Sinai Health System said in a prepared statement.

Late last month, Abbott said that it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation.

In case you missed it

RSS From Medical Design & Outsourcing

  • FDA approves Medtronic’s spinal cord stimulation for chronic pain from diabetic neuropathy
    Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain. The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy. Get the full story at our sister site, MassDevice. The post FDA approves Medtronic’s spinal cord stimulation […]
  • ‘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 mm. “It’s itty bitty,”… […]
  • Hantel appoints VP of business development
    Hantel recently announced that it appointed Ron Balogh as VP of business development. The Hayward, California-based medtech design and contract manufacturing company appointed Balogh on Jan. 3. He will be responsible for serving the company’s current clients and growing the company by improving communications and its presence within the industry. Get the full story on… […]
  • iRhythm plans silent AFib screening pilots, high-level hires and Zio Watch evaluations
    iRhythm Technologies (NSDQ:IRTC) has big plans for 2022 and its remote external electrocardiogram monitors as the medical device developer gears up for growth. President and CEO Quentin Blackford is looking to hire an international general manager among other roles in the coming months, he told Medical Design & Outsourcing after presenting at this month’s 2022… […]
  • Innophase announces next-gen low-power WiFi modules
    Innophase (San Diego) recently announced its next-generation Talaria Two INP1014 and INP1015 WiFi plus BLE5 modules. The new modules are 40% smaller than the previous INP1010 and INP1011 platforms. INP1014 and INP1015 can enable edge-of-network IoT devices, including medical wearables, that require low power consumption and a direct-to-cloud connection, according to the company. The platforms… […]
  • Plastics and medical devices: Changes for safety and cost
    The move toward polypropylene and polyethylene in medical devices requires new manufacturing and assembly solutions such as ultrasonic and laser welding. Didier Perret, Emerson Plastics are ubiquitous in medical applications thanks to their light weight, durability and flexibility, among other attributes. However, concern has been increasing in recent years about the possible negative effects of… […]
  • Medtronic’s recall of HawkOne system is Class I
    The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind. So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier… […]
  • January 2022 Issue: The pandemic tested Medtronic’s mettle
      The pandemic tested Medtronic’s mettle: Its CFO explains how How Abbott seeks to improve care, health inequities for people with cardiovascular disease Medtech’s biggest personnel changes in 2021 The top 5 medtech news stories of 2021 Some thoughts for medtech leaders in 2022 Starting our third year of the COVID-19 pandemic, I wonder when… […]
  • Feinstein Institutes researchers develop tiny implantable neurostimulator for mouse studies
    Researchers have developed a novel, fully implantable wireless bidirectional vagus nerve stimulation (VNS) and sensing device for mice. Engineers and researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research published details about the device and its capabilities in Biosensors and Bioelectronics. They think the device has the potential to transform how… […]
  • MIT team working on all-in-one diabetes management devices
    MIT researchers are touting a platform aimed at helping patients maintain healthy glucose levels by streamlining the diabetes management process. The MIT researchers say it’s hard for people with diabetes to maintain a treatment regimen. Typically at every meal, they need to estimate carbohydrate content, draw blood to measure blood glucose levels, and calculate the… […]
  • Element expands life sciences testing business with pharma, biotech capabilities
    Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries. The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to… […]