Medical Devices


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    Permission granted by Element Biosciences
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    Element raises $277M to challenge Illumina in sequencing market

    The startup claims companies that choose its device over Illumina’s sequencer can save almost $1.5 million in three years.

    By July 12, 2024
  • J&J limits use of Megadyne electrodes due to burn risk

    The FDA said 15 injuries have been tied to the use of three models of Megadyne patient return electrodes.

    By July 12, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
  • 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 finalizes guidance on studying opioid use disorder treatments

    The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.

    By July 12, 2024
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    Deep Dive

    FDA’s lab developed test rule could be first check on agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    By , July 11, 2024
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    Courtesy of BD
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    FDA warns BD blood culture bottle shortage could impact diagnosis

    BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.

    By July 11, 2024
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    Courtesy of Medtronic
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    Medtronic recalls endotracheal tubes over blockage risk

    The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.

    By July 11, 2024
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    Mark Wilson via Getty Images
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    Federal officials step down from health AI group’s board

    HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.

    By Emily Olsen • July 10, 2024
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    iStock via Getty Images
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    Roche wins CE mark for its first CGM

    The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

    By Updated July 10, 2024
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    Pulse drops 510(k) plan for PFA device after FDA requests clinical data

    Analysts said the AFib device is now unlikely to come to market before late 2026.

    By July 9, 2024
  • A picture of a woman talking to a nurse on an MRI tomography machine at a hospital.
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    FG Trade Latin via Getty Images
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    Philips recall of imaging coils tied to 12 injuries

    Several models of coils used in MRI scanners were recalled due to the risk of overheating, which can cause serious burns.

    By July 9, 2024
  • Masimo's Stork baby monitoring boot, smartphone app and camera are displayed.
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    Courtesy of Masimo
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    Masimo offered up to $950M for consumer business

    Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.

    By July 9, 2024
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    Baxter considers sale of kidney care unit to PE firm: WSJ

    Carlyle Group could reportedly pay more than $4 billion for Baxter’s Vantive business.

    By July 8, 2024
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    BD to close Ireland facility, putting 170 jobs at risk

    A company spokesperson said the decision follows a recent review and reflects a push to improve operational efficiency.

    By July 8, 2024
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    Mario Tama / Staff via Getty Images
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    Masimo employees rally around CEO Kiani as proxy fight looms

    Hundreds of healthcare engineers have joined managers to support founder and CEO Joe Kiani as he battles an activist shareholder for control of the company.

    By July 3, 2024
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    Zorica Nastasic via Getty Images
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    Alcon buys Belkin Vision for $81M upfront

    Alcon will gain access to a laser treatment for glaucoma that it plans to sell in the U.S. by the end of the year.

    By July 3, 2024
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    Merit Medical pays Endogastric $105M for acid reflux treatment

    Merit expects the device to add around $30 million in annual sales.

    By July 2, 2024
  • Five syringes side by side with different tips.
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    Retrieved from Cardinal Health on July 02, 2024
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    FDA continues crackdown on plastic syringes made in China

    The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.

    By July 2, 2024
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    Sarah Silbiger via Getty Images
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    FDA to expand total product life cycle program

    Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.

    By July 2, 2024
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Masimo COO says he’ll resign if CEO Kiani is forced out

    Activist investor Politan Capital Management is attempting to remove longtime Masimo leader Joe Kiani, claiming the company lacks independent oversight.

    By July 1, 2024
  • A sign with company logo in red on a white background at the entrance to Johnson & JOhnson medical device unit
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    Mario Tama/Getty via Getty Images
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    Medtech M&A may pick up after mixed start to 2024: analysts

    The annual number of medtech acquisitions is on course to slump to its lowest level since 2017, according to Needham.

    By July 1, 2024
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    FDA walks back injury, death reports on recent Philips BiPAP recall

    The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.

    By Updated July 11, 2024
  • Nick Jonas, Dexcom
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit
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    Dexcom to lay off 535 employees in California

    A company spokesperson said Dexcom is centralizing its U.S. manufacturing operations in Arizona and repurposing its San Diego facility.

    By June 27, 2024
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    Courtesy of HP
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    Medtronic CFO Karen Parkhill leaving for HP

    Truist analysts wrote that “there could be some investor angst until a permanent successor is announced.”

    By June 27, 2024
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    Peter Macdiarmid via Getty Images
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    Zimvie mulls sale after takeover approaches: Bloomberg

    Zimvie is reportedly working with an adviser to assess its options after strategic investors and industry players showed interest in a deal.

    By June 26, 2024
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    Courtesy of Dexcom
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    Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech.

    Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.

    By June 26, 2024