Medical Devices: Page 28

  • Capstan Medical's Dan Wallace and Maggie Nixon stand in a hallway.
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    Permission granted by Capstan Medical
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    Capstan brings surgical robot to valve replacement

    Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.

    By • March 11, 2025
  • A female nurse operates a touch screen in a medical clinic.
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    Getty Images
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    ECRI warns insufficient AI governance threatens patient safety

    ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.

    By • March 11, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
  • Image shows a spinal medical device.
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    Courtesy of Orthofix
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    Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle

    Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO, CFO and CLO. Now, a court case is illuminating the story behind the terminations.

    By Maura Webber Sadovi • March 10, 2025
  • Close up of a person's hands with a pulse oximeter clipped on their pointer finger.
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    Getty Images
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    New FDA pulse oximetry guidelines could stall under Trump

    The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.

    By • March 10, 2025
  • Dexcom's Stelo continuous glucose monitor.
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    Courtesy of Business Wire
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    Dexcom receives warning letter based on FDA inspections of 2 plants

    The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.

    By • March 10, 2025
  • A closeup of an entryway that reads the Federal Trade Commission.
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    Getty Images
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    FTC challenges $627M private equity takeover of Surmodics

    The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition.”

    By • March 7, 2025
  • A shipping container at the Port of Los Angeles on Sept. 20, 2024.
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    Mario Tama via Getty Images
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    Trump tariffs

    Illumina’s DNA sequencers hit with China import ban

    Illumina is not banned from operating in the country and will continue to serve its existing customers, a company spokesperson said.

    By • March 6, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific leads $175M investment in 4C Medical

    The money will support an ongoing pivotal trial of 4C Medical Technologies' transcatheter mitral valve replacement device in the U.S. and Europe.

    By • March 6, 2025
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips pulls endovascular implant from market after 20 injuries

    Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.

    By • March 5, 2025
  • President Donald Trump addresses reporters during a press briefing at the White House on March 3, 2025.
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    Andrew Harnik via Getty Images
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    Trump’s trade war heats up as countries retaliate against tariffs

    Mexico, Canada and China all announced they would counter the president's orders after additional duties went into effect this week.

    By Phil Neuffer , Edwin Lopez , Max Garland • March 4, 2025
  • A portrait of a smiling person dressed in business attire on a white background.
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    Permission granted by Staar Surgical
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    Staar Surgical names Stephen Farrell as CEO

    Farrell replaces Tom Frinzi on the heels of a challenging year for the eye implant maker marked by a demand slowdown in China, its largest market.

    By • March 4, 2025
  • President Donald Trump, joined by Secretary of Commerce Howard Lutnick, signs an executive order on reciprocal tariffs in the Oval Office at the White House on Feb. 13, 2025 in Washington, DC
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    Andrew Harnik via Getty Images
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    Medical device firms brace for effect of White House tariffs

    President Donald Trump upped tariffs on China and said delayed tariffs on Mexico and Canada would take effect. Catch up on MedTech Dive’s latest coverage.

    By • March 4, 2025
  • President Donald Trump addresses reporters at the White House on March 3, 2025.
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    Andrew Harnik via Getty Images
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    Trump hikes tariffs on China by 10%

    The president also maintained that the pause on duties for Canada and Mexico will come to an end Tuesday.

    By Phil Neuffer • Updated March 3, 2025
  • FDA headquarters sign
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    Getty Images
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    Olympus recalls lung biopsy devices linked to 26 serious injuries

    The FDA, which published a Class I recall notice, said the tip of the guide sheath has detached from some devices and fallen off in the patient.

    By • March 4, 2025
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    FDA recall notice details J&J pause of Varipulse

    Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery.

    By • March 3, 2025
  • Two doctors look at two computer screens that have medical images of a patient's brain.
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    Courtesy of Brainomix
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    Medtronic partners with Brainomix on AI stroke tool

    Medtronic also recently teamed with Tempus to assess the use of artificial intelligence to identify people eligible for interventions like TAVR.

    By • Feb. 28, 2025
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina to lay off 96 San Diego employees

    The latest job cuts at Illumina’s California headquarters are not part of a broad-based reduction, a company spokesperson said.

    By • Feb. 28, 2025
  • President Donald Trump speaks during a cabinet meeting at the White House on Feb. 26, 2025.
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    Andrew Harnik via Getty Images
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    Canada and Mexico tariffs will take effect March 4, Trump confirms

    The president will also impose an additional 10% import tax on China next week and hinted at plans to soon levy 25% duties on the European Union.

    By Phil Neuffer • Feb. 27, 2025
  • Wall Street sign with U.S. flags in background
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    Getty Images
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    Teleflex to split in 2, buy Biotronik assets for $791M among slew of actions

    Teleflex, whose shares sank nearly 20% Thursday, will acquire most of Biotronik’s vascular intervention assets. Teleflex also announced a CFO transition.

    By • Feb. 27, 2025
  • A person sits at a desk, smiling, with a square device on top of a stack of notebooks. They are looking at a laptop.
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    Permission granted by Tandem Diabetes Care
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    Tandem’s insulin pump tech wins FDA nod for Type 2 diabetes

    Tandem is following competitor Insulet’s lead with the second automated insulin delivery system indicated for Type 2 diabetes.

    By • Feb. 27, 2025
  • A person lays in front of a radiation therapy machine with both arms up while another person assists them.
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    Courtesy of Elekta
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    Elekta CEO Gustaf Salford to leave after board sees need for new leader

    Laurent Leksell, Elekta’s chairman of the board, said the company needs “new leadership that can further intensify the focus on improving profitability and strengthen growth.”

    By • Feb. 27, 2025
  • Aerial view of Shanghai at night
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    Getty Images
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    Staar Surgical to lay off 115 people in California

    Staar’s job cuts come “amid ongoing macroeconomic and geopolitical challenges that have pressured the business,” a spokesperson said. Demand in China, the company’s largest market, has slowed.

    By • Feb. 26, 2025
  • exterior of the U.S. Department of Health and Human Services
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    Alex Wong via Getty Images
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    CAP urges HHS to revoke lab developed test rule, citing Trump order

    The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”

    By • Feb. 26, 2025
  • Thermo Fisher Scientific
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    Courtesy of Thermo Fisher Scientific
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    Thermo Fisher to buy Solventum’s purification and filtration unit for $4.1B

    Wall Street applauded the deal, sending shares of Solventum, the 3M spinoff, up 10% on Tuesday.

    By • Feb. 25, 2025
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    FDA brings back some fired device staff

    An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to return.

    By • Feb. 24, 2025