Medical Devices: Page 37

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    Mario Tama via Getty Images
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    J&J medtech fails to meet growth expectations

    CFO Joe Wolk told investors Wednesday that Johnson & Johnson’s medical device business missed the company’s 5%-7% growth forecast in the second quarter.

    By • July 17, 2024
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo sues activist investor Politan, postpones annual meeting

    The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.

    By • July 16, 2024
  • 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
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    Sarah Silbiger via Getty Images
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    FDA creates communication ‘super office’ at CDRH

    The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.

    By • July 16, 2024
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    J&J, Abbott and Intuitive start medtech earnings season

    The companies’ financial results will offer a glimpse at the current health of medtech markets.

    By • July 16, 2024
  • A corporate building for Edwards Lifesciences.
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    Courtesy of Edwards Lifesciences
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    Edwards to acquire Innovalve, stake in Affluent Medical

    The heart valve specialist said in a federal filing that it expects to pay $300 million in cash for Innovalve Bio Medical when the deal closes.

    By • July 15, 2024
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    Courtesy of Hamilton Medical
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    Hamilton recalls ventilators that may fail to restart

    One death and one injury have been tied to the safety problem, the Food and Drug Administration said in a recall notice.

    By • July 15, 2024
  • A picture of Element Biosciences' Aviti system against a black background.
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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
  • A green rectangular pad with the words "Mega 2000 Reusable Patient Return Electrode"
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    Retrieved from Food and Drug Administration.
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    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
  • 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
  • Loper decision ending Chevron deference doctrine
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    Anna Moneymaker / Staff via Getty Images
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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
  • A picture of several blood culture vials against a white background.
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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
  • 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 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
  • The front of the department of health and human services building with a sign in front of the exterior building
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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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    Sarah Silbiger via Getty Images
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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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    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
  • Close up of a machine with several tubes, some of which are red.
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    Getty Images
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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
  • A picture of Masimo's headquarters building.
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    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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    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
  • A picture of a woman suffering from chest pain sitting on sofa in living room at home.
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    Getty Images
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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
  • The sign identifying the FDA headquarters in front of its building in White Oak, Maryland.
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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