The Latest

  • A patient recovers after a total knee replacement surgery.
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    Sasirin Pamai via Getty Images
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    Globus Medical gets FDA nod for ortho robot

    With the clearance, Globus could gain share in the roughly $15 billion market for reconstructive orthopedic surgery, RBC Capital Markets analyst Shagun Singh said. 

  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA official sets out approach to AI in medical devices

    Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.

  • 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 buys Silk Road Medical for $1.26B

    Silk Road developed a minimally invasive procedure to prevent stroke in patients with carotid artery disease.

  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic’s president of global regions set to retire in June

    Medtronic made Rob ten Hoedt one of four regional leaders after it bought Covidien almost 10 years ago.

  • Chiquita Brooks-LaSure speaks behind a podium in front of a black background.
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    Chip Somodevilla via Getty Images
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    Senators urge CMS to create AI payment pathway

    Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.

  • A picture of a doctor looking at an X-ray screen during a procedure.
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    Permission granted by Boston Scientific
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    PFA devices are changing AFib treatment. The next wave could grow the market further.

    New pulsed field ablation systems from Boston Scientific and Medtronic are already reshaping the cardiac ablation market, but upcoming devices could spur even greater adoption.

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    Merit Medical recalls plastic syringes made by Jiangsu Shenli

    Merit’s recall comes amid broader FDA scrutiny of plastic syringes made in China.

  • 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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    FDA creates transparency principles for AI in medical devices

    The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

  • A sign announces the company name at Agilent's headquarters building in Santa Clara, California.
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    Permission granted by Agilent
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    Agilent to cut 3% of employees as sluggish lab equipment market persists

    An Agilent spokesperson said the layoffs follow job cuts announced late last year amid a slower-than-expected market recovery.

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    Sarah Silbiger via Getty Images
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    Teleflex catheter kit recall linked to 31 injuries, 3 deaths

    Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.

  • Dental tools and masks sit inside a two trays in a machine, with the door open.
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    Guillermo Spelucin Runciman via Getty Images
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    Medtech group updates EtO standard for first time in 25 years

    The Association for the Advancement of Medical Instrumentation said the changes incorporate new technologies and address industry challenges.

  • A picture of a doctor consulting about an X-ray with a patient.
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    SDI Productions via Getty Images
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    Zimmer, RevelAi partner to sell AI tool for orthopedic care

    RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.

    Updated June 14, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Medline pulls thousands of endotracheal tubes due to risk of airway blockage

    Medline asked hospitals to immediately identify and destroy any affected devices.

  • An American flag waves in front of the Department of Justice exterior. It is a neo-classical building with columns.
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    Kevin Dietsch / Staff via Getty Images
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    Masimo embroiled in dual DOJ, SEC probes

    Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.

  • A picture of Philips' Duo Venous Stent System against a white background.
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    Courtesy of Philips
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    Philips launches stent system to restore blood flow in blocked veins

    Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.

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    Kardium raises $104M to develop pulsed field ablation system

    Kardium will use the funding to complete a clinical study for pursuing regulatory approvals and build its manufacturing, clinical support and commercial teams.

  • A doctor checks the knee of a patient seated on an examination table.
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    PeopleImages via Getty Images
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    Zimmer partners with Think Surgical to launch knee surgery robot

    J.P. Morgan analysts said the move is a “low cost way of adding more robotic options” for Zimmer, but they were still unsure about the added value of the partnership.

  • A female doctor and senior patient discuss medical records.
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    SDI Productions via Getty Images
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    Women underrepresented in trials of high-risk medical implants: study

    A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.

  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    Abbott issues recall for Heartmate system monitor

    Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.

  • 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 names new leaders of imaging and ultrasound units

    Roland Rott will become CEO of GE Healthcare’s imaging business, while Philip Rackliffe will lead a combined ultrasound and image guided therapies segment.

  • The exterior of a U.S. Bankruptcy Courthouse.
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    GussWilder for iStock via Getty Images
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    Vyaire Medical files for Chapter 11 bankruptcy

    CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.

  • A person stands with a white, circular device attached to their upper arm.
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    Permission granted by Abbott
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    Abbott ramps up over-the-counter CGM race with new sensors

    Abbott will launch two over-the-counter glucose monitors in the U.S., competing directly with Dexcom’s Stelo.

  • Boston Scientific's Farapulse pulsed field ablation device.
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    Permission granted by Boston Scientific
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    Pulsed field ablation to ‘cannibalize’ radiofrequency, cryo: Needham

    Boston Scientific is forecast to gain the largest share of the U.S. ablation catheter market in the next 12 months, at the expense of Abbott and J&J.

  • Two carts have mounted screens and surgical tools on them.
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    Courtesy of Johnson & Johnson
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    J&J wins expanded FDA clearance for knee surgery robot

    Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker.

  • 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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    CISA warns of cybersecurity risks in Baxter products

    The cybersecurity notices covered vulnerabilities identified in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool.

    Updated June 10, 2024