Medical Devices: Page 4

  • A professional photo of Egeland smiling and standing in front of a window.
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    Courtesy of Solventum
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    Solventum names Egeland as chief medical officer

    Ryan Egeland, former CEO and co-founder of Crossfire Medical, rounds out the leadership team for the 3M spinoff.

    By • Oct. 11, 2024
  • A picture of a medical catheter against a white background.
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    Courtesy of Abbott
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    Abbott enrolls pivotal PFA study 4 months ahead of schedule

    The company reported the enrollment milestone alongside news that it received clearance to sell its Advisor HD Grid X Mapping Catheter and started a trial of its Tactiflex Duo Ablation Catheter.

    By • Oct. 11, 2024
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • A woman suffering from a migraine (illustrative)
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    Prostock-Studio via Getty Images
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    Shiratronics raises $66M for trial of neuromodulation migraine device

    The funding will support the trial, premarket approval application and initial commercial launch of a system that could interrupt or change the transmission of pain signals to the brain.

    By • Oct. 10, 2024
  • An overhead view of an industrial building affected by flooding, trucks and workers are on the ground in the surrounding area.
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    Retrieved from Aerial Lens on October 10, 2024
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    Baxter ups IV fluid allocations amid supply shortages

    As hospitals around the U.S. report IV fluid shortages, Baxter has increased supply allocations for direct customers and distributors. It plans on returning to 90% to 100% allocation of certain supplies by the end of 2024.

    By • Oct. 10, 2024
  • CMR Surgical interim CEO Massimiliano Colella is shown in a headshot.
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    Permission granted by CMR Surgical
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    CMR Surgical CEO Bose steps down

    Massimiliano Colella, who joined the surgical robotics firm in late 2023, was named interim CEO.

    By • Oct. 10, 2024
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    Daniel Karmann/Picture-Alliance/DPA/AP

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    Deep Dive

    The number of AI medical devices has spiked in the past decade

    The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.

    By , • Oct. 9, 2024
  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Tim Boyle via Getty Images
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    AHA asks Biden administration for relief amid IV fluid shortage from Hurricane Helene

    Hospitals have been contending with shortages of the life-saving supplies after Hurricane Helene damaged Baxter's manufacturing plant in North Carolina, according to the American Hospital Association.

    By Susanna Vogel • Oct. 9, 2024
  • An aerial view shows a large plant surrounded by trucks, mounds of dirt and pools of water.
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    Retrieved from Aerial Lens on October 08, 2024
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    Baxter says no structural damage at North Carolina site hit by Hurricane Helene

    The facility also has access to water and power. Baxter expects to share production plans over the next two weeks.

    By • Oct. 8, 2024
  • An image of Abbott's TriClip device to repair the tricuspid valve.
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    Permission granted by Abbott
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    CMS begins national coverage review for tricuspid repair

    The agency will consider national reimbursement for new tricuspid transcatheter repair devices, including Abbott’s Triclip, in Medicare patients with a leaky tricuspid heart valve.

    By • Oct. 8, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    Mercury Medical recalls emergency resuscitators

    Healthcare professionals use the devices to provide newborns and infants with emergency breathing support.

    By • Oct. 8, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    Smiths recalls ventilators over risk of oxygen flow disruption

    Smiths has grappled with multiple quality issues and recalls over the past few years. Two recent recalls focus on problems with portable ventilators.

    By • Oct. 7, 2024
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic recalls Minimed insulin pumps for reduced battery life

    The company said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S. that could be linked to the problem.

    By • Oct. 7, 2024
  • An overhead view of an industrial building affected by flooding, the surrounding exterior is covered in dirt and sediment.
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    Retrieved from Aerial Lens on October 04, 2024
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    Baxter unsure when North Carolina facility hit by Hurricane Helene will be operational

    As access challenges to the site continue, Baxter has limited purchases of certain products to avoid stockpiling, manage inventory and minimize disruption to patient care.

    By • Oct. 4, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Independent lab fires back after Philips sues over testing results

    PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”

    By • Oct. 3, 2024
  • Becton Dickinson's headquarters, viewed from overhead, are surrounded by a green lawn.
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    Permission granted by Becton Dickinson
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    BD agrees to settle most of its hernia mesh litigation

    The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

    By • Oct. 3, 2024
  • Red human heart drawing on blue background
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    Jolygon via Getty Images
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    FDA authorizes Pi-Cardia’s valve-in-valve TAVR device

    Pi-Cardia designed the Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement.

    By • Oct. 3, 2024
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips issues fix for ventilator problems linked to 9 injuries, 1 death

    Philips is asking customers to immediately install a software update to address several new and previously reported safety issues, the FDA said. 

    By • Oct. 2, 2024
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    Getty Images/Staff via Getty Images
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    Integer sells non-medical business for $50M

    After making nearly $550 million worth of acquisitions in the past few years, the medical device contract manufacturer will use proceeds from the sale to pay down debt.

    By • Oct. 2, 2024
  • A white and gray mammography machine is in an empty room.
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    Courtesy of Siemens Healthineers
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    Siemens Healthineers wins FDA approval for 3D mammography system

    The 3D capabilities are part of Siemens’ first completely redesigned mammography platform in over a decade.

    By • Oct. 2, 2024
  • A person stands in front of the screen of a machine on wheels, near a sign that says "GE HealthCare"
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    Stringer via Getty Images
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    GE Healthcare gets FDA nod for new PET imaging agent

    Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.

    By • Oct. 1, 2024
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    halbergman via Getty Images
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    Top medtech conferences in 2025

    The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.

    By • Oct. 1, 2024
  • A picture of Synchron's brain-computer interface device against a white background.
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    Courtesy of Synchron
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    Synchron’s brain-computer interface tech meets safety goal

    The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.

    By • Oct. 1, 2024
  • A windowed building surrounded by trees with a sign "Baxter" in front
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    Tim Boyle via Getty Images
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    Baxter closes dialysis solutions facility due to Hurricane Helene damage

    More than 2,500 people work at the facility, which is Baxter’s largest manufacturing site. The company is still working to fully assess the damage.

    By • Updated Sept. 30, 2024
  • A picture of Masimo's headquarters building.
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    Mario Tama / Staff via Getty Images
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    What’s next at Masimo after CEO Kiani’s exit?

    Investors are waiting to learn the next steps for the patient monitoring company after a hard-fought proxy battle, including how a separation of its consumer business could play out.

    By • Sept. 30, 2024
  • FDA headquarters with sign in foreground
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    Sarah Silbiger via Getty Images
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    Establishment Labs wins FDA approval for Motiva breast implants

    Motiva is the first new breast implant to receive premarket approval since 2013, according to Establishment Labs, and enters a market reshaped by safety issues linked to other products.

    By • Sept. 30, 2024