Medical Devices: Page 11

  • A person walks in a forest with a square device taped to their thigh.
    Image attribution tooltip
    Courtesy of Tandem Diabetes Care
    Image attribution tooltip

    Tandem names Jean-Claude Kyrillos as chief operating officer

    The appointment gives Kyrillos a leading role in work to expand the insulin delivery company’s global operations and achieve profitable growth.

    By • June 21, 2024
  • J&J HQ
    Image attribution tooltip
    Mario Tama via Getty Images
    Image attribution tooltip

    J&J creates open digital platform for surgical applications

    J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.

    By • June 21, 2024
  • Front sign of FDA building Explore the Trendline➔
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip
    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • A patient recovers after a total knee replacement surgery.
    Image attribution tooltip
    Sasirin Pamai via Getty Images
    Image attribution tooltip

    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. 

    By • June 20, 2024
  • A person holds a sticker over a brown spot on another person's shoulder.
    Image attribution tooltip
    Retrieved from Dermtech on June 20, 2024
    Image attribution tooltip

    Dermtech files for Chapter 11, lays off 20% of staff

    The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.

    By • June 20, 2024
  • Barbed wire sits atop a chain-link fence.
    Image attribution tooltip
    David McNew via Getty Images
    Image attribution tooltip

    Former Stimwave CEO gets 6 years in prison for fake device scheme

    The case centered on allegations that Stimwave marketed a dummy piece of plastic as a receiver of radiofrequency energy.

    By • June 20, 2024
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
    Image attribution tooltip
    Sarah Silbiger/Getty Images via Getty Images
    Image attribution tooltip

    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.

    By • June 18, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    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.

    By • June 18, 2024
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.

    By • June 18, 2024
  • A picture of a doctor looking at an X-ray screen during a procedure.
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    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.

    By • June 17, 2024
  • Food And Drug Administration Headquarters In Maryland
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    Merit Medical recalls plastic syringes made by Jiangsu Shenli

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

    By • June 17, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.

    By • June 17, 2024
  • Dental tools and masks sit inside a two trays in a machine, with the door open.
    Image attribution tooltip
    Guillermo Spelucin Runciman via Getty Images
    Image attribution tooltip

    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.

    By • June 14, 2024
  • A sign announces the company name at Agilent's headquarters building in Santa Clara, California.
    Image attribution tooltip
    Permission granted by Agilent
    Image attribution tooltip

    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.

    By • June 14, 2024
  • Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.

    By • June 14, 2024
  • the FDA Headquarters
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    Medline pulls thousands of endotracheal tubes due to risk of airway blockage

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

    By • June 13, 2024
  • An American flag waves in front of the Department of Justice exterior. It is a neo-classical building with columns.
    Image attribution tooltip
    Kevin Dietsch / Staff via Getty Images
    Image attribution tooltip

    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.

    By • June 13, 2024
  • A picture of Philips' Duo Venous Stent System against a white background.
    Image attribution tooltip
    Courtesy of Philips
    Image attribution tooltip

    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.

    By • June 13, 2024
  • Image attribution tooltip
    Fotolia
    Image attribution tooltip

    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.

    By • June 12, 2024
  • A female doctor and senior patient discuss medical records.
    Image attribution tooltip
    SDI Productions via Getty Images
    Image attribution tooltip

    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.

    By • June 12, 2024
  • A doctor checks the knee of a patient seated on an examination table.
    Image attribution tooltip
    PeopleImages via Getty Images
    Image attribution tooltip

    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.

    By • June 12, 2024
  • Food And Drug Administration Headquarters In Maryland
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.

    By • June 11, 2024
  • The exterior of a U.S. Bankruptcy Courthouse.
    Image attribution tooltip
    GussWilder for iStock via Getty Images
    Image attribution tooltip

    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.

    By • June 11, 2024
  • A person stands in front of the screen of a machine on wheels, near a sign that says "GE HealthCare"
    Image attribution tooltip
    Stringer via Getty Images
    Image attribution tooltip

    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.

    By • June 11, 2024
  • A person stands with a white, circular device attached to their upper arm.
    Image attribution tooltip
    Permission granted by Abbott
    Image attribution tooltip

    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.

    By • June 10, 2024
  • Two carts have mounted screens and surgical tools on them.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    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.

    By • June 10, 2024