Medical Devices: Page 2


  • J&J HQ
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    Mario Tama via Getty Images
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    J&J’s Megadyne discontinues pediatric electrode pad after burn reports

    Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures when the electrode pads were used.

    By May 13, 2024
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    Route 92 catheter recall tied to 2 injuries, 1 death

    The affected devices were manufactured by an outside supplier, not Route 92, and had product quality problems.

    By May 13, 2024
  • Trendline

    The EU Medical Device Regulation

    While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.

    By MedTech Dive staff
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Masimo offers Politan a concession to avoid second proxy fight

    Activist investor Politan immediately snubbed Masimo’s offer to accept one nominee to its board, insisting two new directors are needed to resolve governance issues at the pulse oximetry specialist.

    By May 10, 2024
  • Close-up of a sign with office building and trees in background
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    Sarah Silbiger via Getty Images
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    FDA posts final guidance on remanufacturing medical devices

    Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.

    By May 10, 2024
  • How stricter EtO regs could shape the medtech industry

    In April, the EPA issued a final rule that would limit emissions of ethylene oxide from device sterilizers. The FDA is also taking actions to help reduce emissions of the toxic sterilant.

    By May 10, 2024
  • A headshot of Jennifer Jones-McMeans, who is smiling in the photo. She is wearing an orange blouse and blue hoop earrings.
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    Permission granted by Abbott
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    Q&A

    Abbott’s Jennifer Jones-McMeans on treating PAD below the knee

    Jennifer Jones-McMeans, a leader in Abbott’s vascular unit, discussed the company’s newly approved stent for the tough-to-treat condition in an interview with MedTech Dive.

    By May 9, 2024
  • An operating room has a table surrounded by screens and several overhead lights, and a surgical robot that says "Mako"
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    Permission granted by Stryker
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    Surgical robots are ‘gift that will keep on giving,’ ortho firms say

    Stryker, Zimmer and Globus reported double-digit sales growth in their robot segments and outlined plans for new products. 

    By May 9, 2024
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
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    Courtesy of Tandem Diabetes Care
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    Tandem reports 224 injuries related to faulty insulin pump app

    A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.

    By May 9, 2024
  • The Getinge Cardiosave intra-aortic balloon pump system
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    Courtesy of Getinge
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    FDA tells providers to stop using Getinge heart devices

    After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.

    By May 9, 2024
  • Two ultrasound machines on wheels with screens showing medical images are side by side.
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    Courtesy of Samsung
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    Samsung Medison to buy AI ultrasound company Sonio

    Sonio’s software uses deep learning to improve image quality. Its software will remain compatible with all ultrasound machines, the company said.

    By May 8, 2024
  • A surgeon holds a piece of surgical mesh for hernia and abdominal wall surgery.
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    Courtesy of Integra
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    Integra still addressing problems at Boston plant

    A third-party audit of the Boston facility identified more issues, forcing Integra to keep Surgimend and Primatrix off the market for the foreseeable future.

    By May 8, 2024
  • Outset Medical's Tablo Hemodialysis System.
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    Courtesy of Outset Medical
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    Outset Medical gets FDA nod for dialysis accessory months after halting sales

    Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.

    By May 7, 2024
  • A procedure is performed in an operating room using CMR Surgical's Versius robotic system.
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    Courtesy of CMR Surgical
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    CMR Surgical names new CFO

    Shlomi Cohen takes over the role as the surgical robotics company focuses on global expansion and competing with market leader Intuitive Surgical.

    By May 7, 2024
  • A baby in a onesie lifts up a foot wearing a Stork monitor boot.
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    Courtesy of Masimo
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    Masimo’s at-home baby monitor cleared for use without prescription

    A proposed separation of Masimo’s consumer business, which is currently under consideration, would likely include the Stork monitoring system.

    By May 7, 2024
  • A coil-shaped device is shown moving through a tube with branching structures around it.
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    Courtesy of Medtronic
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    Medtronic wins approval to sell renal denervation device in China

    Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.”

    By May 7, 2024
  • Boxes move on a conveyor belt next to a wall that says 'Next Beam'
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    Permission granted by Nextbeam
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    Deep Dive

    EtO causes cancer. Device sterilizers are scrambling to find alternatives.

    No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.

    By May 6, 2024
  • A union jack flag waves in the wind
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    Ramberg via Getty Images
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    UK sets out position on regulating AI as a medical device

    Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.

    By May 3, 2024
  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    Cue Health to cut 230 employees

    Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.

    By May 3, 2024
  • Cardinal receives FDA warning letter over unapproved syringes

    The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.

    By May 2, 2024
  • Philips CPAP machine
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    N/A via Getty Images
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    Philips reaches major settlements related to respiratory devices recall

    A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.

    By May 2, 2024
  • Wooden cubes that spell out "M&A"
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    Nastassia Samal via Getty Images
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    Medline to buy Ecolab’s surgical products for nearly $1B

    The medical products supplier will acquire Ecolab’s sterile drapes and fluid temperature management systems.

    By May 1, 2024
  • A cylindrical device on the left with a wifi signal, next to a black rounded device and a smartphone showing a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics gets FDA clearance to pair CGM implant with insulin pumps

    Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.

    By May 1, 2024
  • Close up of a person holding a small, cylindrical device in the palm of their hand.
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    Courtesy of Endomagnetics
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    Hologic to buy Endomagnetics for $310M

    Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.

    By April 30, 2024
  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    Abbott wins FDA approval for Esprit resorbable scaffold

    While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch.

    By April 30, 2024
  • An oversized pair of scissors looms over seven workers sitting in office chairs suspended by strings.
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    mathisworks via Getty Images
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    Medtronic to lay off 44 employees in California

    Medtronic’s latest layoff plan adds to what has become a long list of job cuts for the medical device industry this year.

    By April 29, 2024