Medical Devices


  • 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
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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
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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
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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
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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
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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 industry wide 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
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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
  • 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
  • Woman using a laptop to contact a medical professional about her health. She is siting at a table in a kitchen and is taking her blood pressure with a blood pressure gauge.
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    SolStock via Getty Images
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    Remote patient monitoring in Medicare needs more oversight: OIG

    Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.

    By Emily Olsen • Sept. 27, 2024
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    Nuthawut Somsuk via Getty Images
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    Mendaera raises $73M to develop handheld robotics platform

    Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.

    By Sept. 27, 2024
  • Jeff Shuren stands in front of a podium.
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    Permission granted by Peyton Helbert / AAMI
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    Lawmakers call for investigation of former FDA device director

    The letter to the health department watchdog follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

    By Sept. 26, 2024
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

    By Sept. 26, 2024
  • A person lays with their arm outstretched and an x-ray camera facing it.
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    Courtesy of Siemens Healthineers
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    Medtronic, Siemens Healthineers partner on spine surgery

    Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.

    By Sept. 25, 2024
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo CEO, founder Kiani resigns

    Michelle Brennan was named acting CEO of the patient monitoring company following Joe Kiani’s defeat in a proxy battle with an activist investor.

    By Sept. 25, 2024
  • Ross Segan is shown in a headshot.
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    Permission granted by FDA
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    FDA names new head of medical device evaluation and quality

    Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

    By Sept. 24, 2024