Medical Devices: Page


  • Multiple black-and-white scans of the lumbar spine next to each other.
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    NuVasive shareholders expected to ‘begrudgingly’ back Globus’ $3.1B takeover amid lack of other bidders

    Analysts said “none of the other major strategic players were in a position to bid on NuVasive — either because they were not interested or were financially tied up in other areas.”

    By • March 22, 2023
  • A rectangular box with arrows on the front says "Medtronic GI Genius"
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    Permission granted by Medtronic
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    Medtronic, Nvidia to combine forces on AI devices, allowing users to create new software

    The companies are working together to allow physicians and developers to build AI applications for Medtronic devices, beginning with the GI Genius endoscopy platform.

    By • March 21, 2023
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    Sarah Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • Accelus' Remi robotic spine system.
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    Spine robot maker Accelus gains another FDA clearance

    The company believes its Remi device, which works with several major imaging systems, can gain traction in the market with its portable design.

    By • March 21, 2023
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    Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts

    The companies have acquired pulsed field ablation devices in recent years, but one surgeon told analysts he prefers Boston Scientific’s device as it doesn’t require general anesthesia, leading to faster patient turnaround.

    By • March 21, 2023
  • Ashley McEvoy, J&J's  worldwide chairman of Medical Devices
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    Permission granted by Johnson & Johnson
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    J&J’s Ashley McEvoy named chair of AdvaMed

    McEvoy, who is J&J’s worldwide chairman of medtech, will lead the trade association’s board for the next two years.

    By • March 20, 2023
  • Medical device opened up on repair table with technician working
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    Permission granted by Quest Inc. / Blaine Herman
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    Sponsored by Quest International

    How OEMs can budget aftermarket service in a recession

    OEMs need to rethink how to deliver scalable, flexible service, especially in economic uncertainty. 

    March 20, 2023
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    Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters

    The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma.

    By • March 20, 2023
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    FDA sets end date for raft of COVID-related shortages that began early in pandemic

    Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

    By • March 20, 2023
  • Supratim Bose
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    Permission granted by CMR Surgical
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    Robot maker CMR Surgical appoints new CEO as it looks to ramp system sales

    Supratim Bose will now lead the rollout of the company’s Versius system.

    By • March 17, 2023
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    Courtesy of U.S. Food and Drug Administration
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    Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources

    Other groups gave a warmer welcome to the plan, with AdvaMed suggesting specific edits without criticizing the overall approach.

    By • March 17, 2023
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    Senseonics grows sales in Q4 despite ‘softer demand’ for CGM implant in US and Germany

    Demand in the U.S. was affected by “a little bit of ambiguity on pricing” ahead of a change to Medicare.

    By • March 17, 2023
  • Medtronic's Sphere-9 ablation catheter.
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    Courtesy of Medtronic
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    Medtronic wins CE mark for ablation device, invests in heart failure monitoring company

    The Affera system gives physicians a choice between pulsed field ablation and radiofrequency to treat atrial fibrillation.

    By • March 16, 2023
  • iRhythm Zio XT
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    iRhythm COO resigns amid restructuring

    Douglas Devine will stay on as a consultant through 2024, as the company goes through a restructuring to become “a larger digital healthcare organization.” 

    By • March 16, 2023
  • Tandem Diabetes Control-IQ
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    Courtesy of Tandem Diabetes
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    Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids

    If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.

    By • March 16, 2023
  • Medical shears and other tools are submerged in a liquid in a metal basin.
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    Getinge buys sterilization firm Ultra Clean Systems for $16M

    The Sweden-based company, which already partnered with Ultra Clean as a distributor, said the deal will “significantly expand” its offerings to sterile reprocessing departments.

    By • March 15, 2023
  • Persons in physician garb demonstrating replacement knee joint
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    Joint replacement business likely to be busy for the next year or more: BTIG analysts

    A backlog of patients and improved staffing at hospitals and surgery centers have the analysts projecting four to six quarters of growth for firms including Stryker and Zimmer Biomet.

    By • March 14, 2023
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    Illumina shares jump 17% after Icahn launches proxy fight

    The activist investor said his board nominees would work to prevent Illumina from “sinking further into the quicksand” in a battle with regulators over the Grail acquisition.

    By • Updated March 14, 2023
  • Professional photo of Julia Strandberg
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    Courtesy of Philips
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    Philips poaches new connected care business leader from Pear

    Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.

    By • March 13, 2023
  • An SVB sign stands outside the bank's headquarters.
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    Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched

    A review of companies covered by analysts reveals no significant direct exposure to SVB’s failure, but startups dependent on venture capital cash may be affected.

    By Peter Green • March 13, 2023
  • Baxter Hillrom Life2000 ventilator
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    Courtesy of Baxter
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    Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation

    Patients can continue to use the devices if they are checked daily and properly maintained, the company said in an announcement posted by FDA.

    By • March 13, 2023
  • A person sits in front of a plate of food, holding a smartphone. They're wearing a patch on their left arm.
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    Courtesy of Insulet Corp.
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    Insulet to join S&P 500 after Silicon Valley Bank ousted

    Shares of the insulin pump maker rose Monday on news that it would join the stock index.

    By • March 13, 2023
  • Chief U.S. District Judge for the District of Columbia Beryl A. Howell
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    Alex Wong via Getty Images
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    Medtech groups lose challenge to digital piracy rule in device repair case

    Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.

    By • March 13, 2023
  • EMS Professional Paramedic Using Tablet Computer to Fill a Questionnaire for the Injured Patient on the Way to Hospital.
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    Gorodenkoff/Shutterstock.com

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    Sponsored by Esper

    Device management for mission-critical care: Maximizing efficiency and effectiveness

    Reduce the complexity of device fleet management to deliver seamless mission-critical care.

    March 13, 2023
  • LivaNova Essenz HLM
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    Courtesy of LivaNova
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    LivaNova receives FDA nod for heart-lung machine

    After beginning its European rollout last month, the UK-based device maker hopes to bring its market-leading position to the U.S.

    By Peter Green • March 10, 2023
  • Attorney Erik Vollebregt
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    Permission granted by Erik Vollebregt
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    Q&A

    Friday Q&A: A regulatory attorney breaks down the EU MDR transition

    Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.

    By • March 10, 2023