Medical Devices: Page 11


  • NeuroOne
    Image attribution tooltip
    Permission granted by NeuroOne
    Image attribution tooltip

    NeuroOne gains FDA clearance for trigeminal nerve ablation

    The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.

    By Aug. 20, 2025
  • CMR Surgical's Chris O'Hara poses in a dark blue suit and tie.
    Image attribution tooltip
    Courtesy of CMR Surgical
    Image attribution tooltip

    CMR Surgical hires Chris O’Hara to drive US robot expansion

    O’Hara joins CMR’s executive team as commercial president and general manager for the U.S., following the FDA’s authorization last fall for its Versius system.

    By Aug. 19, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendlineâž”
    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 modern two-story commercial office building with a mix of gray and wood paneling on the exterior. Large glass windows dominate both floors, and the front entrance features the "Medtronic" logo above double glass doors. The surrounding area includes a few small shrubs and empty parking spaces in front.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Medtronic recall of heart vent catheters tied to 3 serious injuries

    The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”

    By Aug. 19, 2025
  • Kardium's Globe mapping and ablation catheter for pulsed field ablation is shown.
    Image attribution tooltip
    Courtesy of Kardium
    Image attribution tooltip

    Heart devices pace medtech’s summer funding flows

    July and August have brought a steady beat of private financings for young medtech companies, with several deals supporting new technologies to treat heart conditions.

    By Aug. 18, 2025
  • Two people talk while a screen displays a medical image.
    Image attribution tooltip
    Courtesy of Philips
    Image attribution tooltip

    Philips will spend $150M to expand manufacturing for AI-enabled tech

    The investment includes increasing manufacturing and research and development capabilities at its Reedsville, Pennsylvania, facility.

    By Aug. 15, 2025
  • President Donald Trump boards Air Force One on Aug. 15, 2025, at Joint Base Andrews, Maryland.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip

    Trump says semiconductor tariffs to come next week

    The president indicated that duties on chips would be “approximately 100%” earlier this month.

    By Phil Neuffer • Aug. 15, 2025
  • Seven watches lined up side to side with different screens and colors.
    Image attribution tooltip
    Courtesy of Apple
    Image attribution tooltip

    Apple updates smart watches with blood oxygen feature after customs ruling

    Apple said it was able to bring a redesigned blood oxygen feature to its devices after a recent U.S. customs ruling.

    By Aug. 14, 2025
  • Reprieve Cardiovascular CEO Mark Pacyna smiles in a headshot.
    Image attribution tooltip
    Permission granted by Reprieve Cardiovascular
    Image attribution tooltip

    Reprieve Cardiovascular raises $61M; Conformal Medical nets $32M for LAAO

    The fresh funding will support pivotal trials in progress and commercialization preparations at the two heart-focused companies.

    By Aug. 14, 2025
  • Vicarious Surgical's robotic system.
    Image attribution tooltip
    Courtesy of Vicarious Surgical
    Image attribution tooltip

    Vicarious Surgical delays robot timeline

    Days into the job, CEO Stephen From said the company no longer expects to begin a clinical trial for its robotic system by the end of the year.

    By Aug. 13, 2025
  • Professional photo of Shan Jegatheeswaran
    Image attribution tooltip
    Permission granted by Johnson & Johnson
    Image attribution tooltip
    Q&A

    Shan Jegatheeswaran shares J&J’s vision for AI in the OR

    By combining surgical video with other insights, Jegatheeswaran hopes Johnson & Johnson can support better outcomes in procedures.

    By Aug. 13, 2025
  • human heart
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Cardiosense appoints John Martin as chief medical officer

    The appointment comes weeks after the company received 510(k) clearance for its wearable heart monitor.

    By Aug. 13, 2025
  • A building with a windowed wall and a sign that reads "Dräger"
    Image attribution tooltip
    Courtesy of Draeger
    Image attribution tooltip

    Draeger removes ventilation filters over misleading carbon dioxide readings

    Hospitals are being advised to stop using the filters after serious injuries were reported related to the problem, the FDA said in a recall notice.

    By Aug. 12, 2025
  • Heartflow
    Image attribution tooltip
    Courtesy of HeartFlow
    Image attribution tooltip

    Heartflow’s IPO raises $364M

    The company’s stock rose in its first two days on public markets, closing on Monday up almost 58% over the IPO price amid investor enthusiasm.

    By Aug. 12, 2025
  • Symbolic of Sino-American relations, the flag of the United States of America and the flag of the Republic of China fly together on flag poles next to each other on a sunny, windy day.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    US to maintain lower tariff rates on China imports for 90 more days

    China also extended its suspension of additional retaliatory duties against U.S. goods, maintaining current rates until November.

    By Max Garland • Aug. 12, 2025
  • Senior woman suffering from pain in wrist at home while sitting on a gray sofa.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    SetPoint Medical secures $140M to fund neuromodulation for arthritis

    Abbott and Boston Scientific are among the investors in SetPoint, whose neurostimulation device gained FDA approval last month.

    By Aug. 11, 2025
  • An illustration of human lungs with a geometrical effect.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Apreo raises $130M for pivotal trial of emphysema device

    The company, which received investment from the venture capital wing of Intuitive Surgical, has designed the device to work in a broader patient population than existing treatments.

    By Aug. 11, 2025
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
    Image attribution tooltip
    Courtesy of Tandem Diabetes Care
    Image attribution tooltip

    Tandem, Insulet monitoring CMS payment proposal for diabetes tech

    The proposal would introduce competitive bidding for insulin pumps and change how Medicare pays for diabetes devices, if finalized.

    By Aug. 8, 2025
  • New Masimo CEO Katie Szyman wears a navy blue jacket and white shirt.
    Image attribution tooltip
    Permission granted by Masimo
    Image attribution tooltip

    Masimo appoints several senior execs, resolves cyber incident

    The pulse oximeter maker is now fully operational after a spring cyberattack and increased its 2025 profit forecast, but investors have raised questions about the status of a partnership with Philips.

    By Aug. 8, 2025
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Boston Scientific updates instructions of devices linked to 17 deaths

    The update covers devices used in procedures to implant the company’s Watchman heart device.

    By Aug. 8, 2025
  • A commercial building displays a “Boston Scientific” sign on its exterior. The structure features a smooth white facade with reflective windows and minimal architectural detailing, set against a partly cloudy sky.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Boston Scientific tells users about defibrillator problem linked to deaths, injuries

    A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

    By Aug. 7, 2025
  • A square screen shows a graph of blood glucose levels and a bolus option.
    Image attribution tooltip
    Courtesy of Tandem Diabetes Care
    Image attribution tooltip

    Tandem insulin pump malfunction linked to 59 injuries

     A problem with speakers in Tandem’s t:slim X2 insulin pumps can cause insulin delivery to stop, the company said.

    By Aug. 7, 2025
  • President Donald Trump speaks during a presentation in the Oval Office of the White House on Aug. 6, 2025, in Washington D.C.
    Image attribution tooltip
    Win McNamee via Getty Images
    Image attribution tooltip

    Trump plans 100% tariffs for semiconductor imports

    Chips are one of several product types currently under Section 232 investigation by the White House, a frequent precursor to duties.

    By Phil Neuffer • Aug. 7, 2025
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    BD commits $35M to expand US syringe production plant

    The company said it has grown capacity by 10% this year, bringing its total U.S. output of the prefilled flush syringes to above 750 million units.

    By Aug. 6, 2025
  • The Federal Trade Commission emblem on the Constitution Center in Washington, D.C.
    Image attribution tooltip
    Laurel Deppen/MedTech Dive
    Image attribution tooltip

    FTC moves to block Edwards’ JenaValve acquisition

    Edwards Lifesciences and JenaValve said they remained committed to completing the deal and would defend the case in court.

    By Aug. 6, 2025
  • A person speaks at a podium.
    Image attribution tooltip
    Elise Reuter/MedTech Dive
    Image attribution tooltip

    Medical device industry says future MDUFA hikes unsustainable

    Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.

    By Aug. 5, 2025