The Latest

  • Medical Science Laboratory with Diverse Multi-Ethnic Team
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    Could the FDA take an indirect approach to regulate LDTs?

    Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

  • Anne Wojcicki speaking event
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    Brad Barket via Getty Images
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    Anne Wojcicki wins bid to buy back 23andMe for $305M

    A nonprofit led by the co-founder and former CEO of 23andMe outbid competitors for nearly all of the company’s assets.

  • The robotic arms and surgeon's console of SS Innovations' SSi Mantra 3 system are pictured.
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    Permission granted by SS Innovations
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    SS Innovations’ robot used in its first cardiac surgery in Americas

    The robot maker, which is expanding globally, believes it can stand out in competition with market leader Intuitive Surgical with a technologically advanced system that is affordable and accessible.

  • Front sign of FDA building
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    Sarah Silbiger via Getty Images
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    Zyno recalls infusion pumps over unvalidated software

    Customers have been asked to stop using the pumps and wait for someone to contact them about exchanging devices.

  • 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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    Centerline recalls guidewire over risk of coating being left in patients

    Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures. No serious injuries or deaths have been tied to the recall.

  • Chris smiles and wears a brown jacket.
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    Permission granted by Abbott
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    Q&A

    Abbott’s new diabetes leader on latest sensors, partnerships and Type 2 coverage

    Ahead of the American Diabetes Association’s Scientific Sessions, Chris Scoggins said Abbott’s ambition is to be the most broadly connected diabetes tech company.

  • Closeup shot of an unrecognizable doctor using a digital tablet.
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    iStock via Getty Images
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    Joint Commission, CHAI partner to develop guidance on health AI

    The guidance should help health systems safely manage and monitor AI tools in a financially sustainable manner, which can be “a real challenge” for providers, said CHAI CEO Dr. Brian Anderson.

    AI
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest partners with MD Anderson to develop cancer risk blood test

    Quest plans to refine, develop and validate the technology and is aiming to launch the test in North America next year.

  • 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 ventilators linked to 2 serious injuries, 1 death

    The recall comes more than one year after Medtronic announced it would exit the ventilator market.

  • U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 14, 2025 in Washington, DC.
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    Anna Moneymaker / Staff via Getty Images
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    RFK Jr. reveals picks for influential vaccine panel

    Days after firing all 17 members of the CDC's Advisory Committee for Immunization Practices, the HHS Secretary named a small new committee that includes multiple vaccine critics.

  • FDA
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    Sarah Silbiger via Getty Images
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    FDA schedules first public MDUFA VI meeting ahead of negotiations

    Officials want to know what current features should be reduced or stopped to “ensure the continued efficiency and effectiveness of the medical device review process.”

  • President Donald Trump boards Air Force One on June 10, 2025, in Joint Base Andrews, Maryland.
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    Anna Moneymaker via Getty Images
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    Trump says tariff deal with China is ‘done’

    The proposed agreement, pending approval from both countries, sets 55% tariffs on imports from China and a 10% rate on U.S. products, the president said Wednesday.

  • A person walks in a forest with a square device taped to their thigh.
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    Courtesy of Tandem Diabetes Care
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    Tandem, Abbott team on insulin delivery with glucose-ketone sensor

    Tandem will integrate its insulin delivery systems with a new dual glucose-ketone sensor being developed by Abbott.

  • A scientist in blue clothing walks past sequencing machines in a Caris Life Sciences tissue laboratory.
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    Courtesy of Caris Lifesciences
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    Caris Life Sciences plans $424M IPO

    Caris, which offers tools for disease diagnosis, therapy selection and treatment monitoring, is the latest company to test the medtech IPO market.

  • A person in a blue pinstripe suit looks straight ahead.
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    Andrew Harnik via Getty Images
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    Vaccine makers face fresh uncertainty after firing of CDC panel

    The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned with Robert F. Kennedy Jr.’s skeptical views, analysts warned.

  • Elekta CEO Jakob Just-Bomholt is pictured in an open-collar white shirt and Navy blue blazer.
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    Courtesy of Elekta
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    Elekta appoints Jakob Just-Bomholt as CEO

    The company cited Just-Bomholt’s strategic leadership, international experience and ability to drive profitable growth and global expansion as evidence he is the right person for the job.

  • Professional photo of Kate Benedict
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    Permission granted by Medtronic
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    Medtronic names Kate Benedict president of acute care and monitoring

    Medtronic had planned to spin out the two units before consolidating them into one segment last year.

  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    Judge rules J&J unit must pay $442M in antitrust case

    A federal judge awarded triple damages after a jury found Biosense Webster withheld support to hospitals that bought reprocessed catheters.

  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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    Baxter recalls Novum pump linked to 1 serious injury

    The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

    Updated June 11, 2025
  • 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 removes tracheostomy tubes due to dislodging risk

    If the tube moves out of place, it could prevent a patient from breathing or block the airway. A Medtronic spokesperson said patient harm was reported in some cases.

  • Blue and yellow flags bearing the European Commission logo fly in front of a building.
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    Carl Court via Getty Images
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    EU plan would limit Chinese device makers in Europe

    The move comes after a recent investigation found Chinese government procurement practices discriminate against EU companies in China’s domestic market.

  • U.S. President Donald Trump watches as Health and Human Services Secretary Robert F. Kennedy Jr. (C) swears in Dr. Mehmet Oz (R) as the Medicare and Medicaid Services Administrator during a ceremony in the Oval Office at the White House on April 18, 2025 in Washington, DC.
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    Andrew Harnik / Staff via Getty Images
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    Tracker

    Trump policies are upending healthcare. Track the effect on the medtech industry here.

    The FDA has rolled out an AI tool agency-wide, while a proposed HHS budget shows large cuts for the National Institutes of Health.

    Updated June 6, 2025