Medical Devices: Page 25

  • Embecta CEO Dev Kurdikar stands at a podium that says "Nasdaq" while people clap around him.
    Image attribution tooltip
    Permission granted by Nasdaq
    Image attribution tooltip

    Embecta gets FDA nod for insulin patch pump

    Embecta’s first patch pump features a larger insulin reservoir, based on feedback from people with Type 2 diabetes.

    By • Sept. 3, 2024
  • A person wearing safety goggles holds a pipette of fluid.
    Image attribution tooltip
    Courtesy of Grail
    Image attribution tooltip

    Illumina avoids fine for Grail purchase in European court victory

    Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

    By • Sept. 3, 2024
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip
    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
  • A photo of Sam Ajizian
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic’s chief medical officer of acute care and monitoring departs for new role

    Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.

    By • Aug. 30, 2024
  • Close-up of a sign with office building and trees in background
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA finalizes Voluntary Malfunction Summary Reporting guidance

    The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.

    By • Aug. 30, 2024
  • A person holding a tablet watches as another person wears VR googles and does exercises with dumbbells.
    Image attribution tooltip
    Courtesy of Penumbra
    Image attribution tooltip

    Penumbra axes virtual reality division, will lay off 71 people

    CEO Adam Elsesser told investors the company’s focus needs to be on its core thrombectomy business as it cut its sales forecast for 2024.

    By • Aug. 29, 2024
  • .
    Image attribution tooltip
    Rob Carr / Staff via Getty Images
    Image attribution tooltip

    Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator

    The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.

    By Emily Olsen • Aug. 29, 2024
  • Two employees work in a clean room pictured through a window at UFP Technologies' Grand Rapids, Michigan, facility.
    Image attribution tooltip
    Retrieved from UFP Technologies on August 27, 2024
    Image attribution tooltip

    UFP to buy device component maker AQF Medical, extending deal spree

    AQF makes foam and thermoplastic components for use in medical devices and packaging.

    By • Aug. 28, 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 receives CE mark for updated TAVR technology

    Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.

    By • Aug. 28, 2024
  • A photo shows Insulet Chief Medical Officer Trang Ly
    Image attribution tooltip
    Permission granted by Insulet
    Image attribution tooltip
    Q&A

    Insulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care

    Automated insulin delivery for Type 2 patients can help change minds among physicians who have been reluctant to prescribe pump therapy, the chief medical officer said in an interview.

    By • Aug. 27, 2024
  • A 3D visualization of red blood cells traveling through a blood vessel.
    Image attribution tooltip
    Kahan Shan via Getty Images
    Image attribution tooltip

    Inari updates label of clot removal device linked to 6 deaths

    Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.

    By • Aug. 27, 2024
  • A picture of Siemens Healthineers' headquarters building in Erlangen, Germany.
    Image attribution tooltip
    Courtesy of Siemens Healthineers
    Image attribution tooltip

    Siemens Healthineers to grow PET imaging with purchase of Novartis assets

    Siemens will pay 200 million euros for the manufacturing and distribution network of Novartis’ radiopharmaceutical molecular imaging business.

    By • Aug. 27, 2024
  • A person runs in a soccer field wearing two white devices taped to their upper arms.
    Image attribution tooltip
    Courtesy of Insulet
    Image attribution tooltip

    Insulet expands Omnipod 5 pump to people with Type 2 diabetes

    The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.

    By • Aug. 26, 2024
  • A person playing pickleball wears a circular patch on their upper arm.
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom prices first over-the-counter glucose monitor

    Known as Stelo, the device is intended for people who don’t take insulin and costs $89 per month.

    By • Aug. 26, 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

    Defibtech recalls chest compression device linked to patient death

    Customers are asked to return affected devices due to a problem in the motor that could stop compressions.

    By • Aug. 26, 2024
  • FDA headquarters with sign in foreground
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA seeks feedback on predetermined change control plans

    The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

    By • Aug. 26, 2024
  • The lobby of Stryker's new headquarters building in Portage, Michigan, is pictured.
    Image attribution tooltip
    Retrieved from Stryker on August 23, 2024
    Image attribution tooltip

    Stryker to add back pain treatment with Vertos Medical buy

    Stryker’s latest purchase comes amid a pickup in medtech M&A, with Johnson & Johnson, Boston Scientific and Edwards Lifesciences all active this year.

    By • Aug. 23, 2024
  • An image of the Procept Biorobotics system against a white background.
    Image attribution tooltip
    Courtesy of Procept Biorobotics
    Image attribution tooltip

    Procept wins FDA clearance for updated prostate surgery robot

    Procept Biorobotics has added AI capabilities and switched to a single-use scope to support mass-market adoption.

    By • Aug. 22, 2024
  • Judges Or Auctioneer Gavel On The Dollar Cash Background
    Image attribution tooltip
    Avosb via Getty Images
    Image attribution tooltip

    Zoll to buy Vyaire’s ventilator business with $37M auction bid

    Vyaire Medical held a virtual auction of assets after filing for Chapter 11 bankruptcy protection in June.

    By • Aug. 21, 2024
  • A Marantz home entertainment system is pictured on a wooden table top with a city skyline at nighttime visible in the background through a window.
    Image attribution tooltip
    Retrieved from Masimo on August 20, 2024
    Image attribution tooltip

    Masimo’s consumer audio brands attract more suitors

    Negotiations with a potential joint venture partner will continue while Masimo initiates discussions with new parties that have expressed interest in the consumer audio business.

    By • Aug. 21, 2024
  • U.S. Government Accountability Office
    Image attribution tooltip
    "Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
    Image attribution tooltip

    FDA’s plan to expand device surveillance faces challenges, GAO finds

    Funding issues and limited use of unique device identifiers are hurdles to expanding an FDA system to monitor medical device safety, the federal watchdog said.

    By • Aug. 21, 2024
  • V-Wave's implantable device for heart failure is shown next to a dime.
    Image attribution tooltip
    Permission granted by Johnson & Johnson
    Image attribution tooltip

    J&J to buy heart failure implant maker V-Wave for up to $1.7B

    J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.

    By • Aug. 20, 2024
  • Image attribution tooltip
    Edwards Lifesciences
    Image attribution tooltip

    Edwards continues M&A spree with Genesis’ TAVR tech

    Edwards, which has made a series of acquisitions in recent months, is also investing $25 million in Singapore-based Genesis Medtech.

    By • Aug. 19, 2024
  • Histosonics' Edison histotripsy system is pictured in an operating room.
    Image attribution tooltip
    Permission granted by Histosonics
    Image attribution tooltip

    Histosonics raises $102M for noninvasive treatment to destroy tumors

    Using sound waves to break down tumor tissue can offer patients with liver cancer an alternative to surgery, radiation and chemotherapy.

    By • Aug. 19, 2024
  • Two people wearing suits stand in between two people talking wearing white coats in a laboratory setting.
    Image attribution tooltip
    Erin Scott / U.S. White House. Retrieved from Flickr.
    Image attribution tooltip

    Biden pledges $150M for medical tech to improve cancer surgery

    Awards include funding for microscopy and imaging tools to help surgeons ensure all cancer is removed during a procedure.

    By • Aug. 16, 2024
  • A picture of Stereotaxis' GenesisX surgical robot against a white background.
    Image attribution tooltip
    Permission granted by Stereotaxis
    Image attribution tooltip

    Stereotaxis earns CE mark for new surgical robot

    CEO David Fischel said the platform, called GenesisX, is designed to address challenges hospitals have faced when installing the company’s earlier robotic systems.

    By • Aug. 15, 2024