Medical Devices


  • A procedure is performed in an operating room using CMR Surgical's Versius robotic system.
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    Courtesy of CMR Surgical
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    The robotic surgery market battle is heating up

    After a busy summer of surgical robotics news, check out MedTech Dive’s roundup of coverage in the space.

    By Aug. 22, 2025
  • U.S. President Donald Trump speaks during a joint press conference with European Commission President Ursula von der Leyen on July 27, 2025, in Turnberry, Scotland.
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    Andrew Harnik via Getty Images
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    MedTech Europe sounds alarm over impact of US-EU tariffs on patients

    The trade group wants the U.S. to eliminate tariffs on medical technologies, warning that “patients cannot be collateral damage in trade tensions.”

    By Aug. 22, 2025
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • FDA
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    Sarah Silbiger via Getty Images
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    More than 1,100 devices have received the FDA’s breakthrough designation

    The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.

    By Aug. 21, 2025
  • U.S. President Donald Trump speaks during a joint press conference with European Commission President Ursula von der Leyen on July 27, 2025, in Turnberry, Scotland.
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    Andrew Harnik via Getty Images
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    US, EU agree to terms of framework trade pact

    The two trading partners documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, auto parts, pharmaceuticals and semiconductors.

    By Philip Neuffer • Aug. 21, 2025
  • Dr. Mehmet Oz sits on a table in front of a namecard bearing his name.
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    Anna Moneymaker/Getty Images via Getty Images
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    AdvaMed urges Dr. Oz to speed Medicare coverage of breakthrough devices

    The medtech trade group wants the CMS to take “bold action” to cut the lag between FDA authorization of devices and Medicare coverage.

    By Aug. 21, 2025
  • A person wearing a black wristband holds a phone that says "103/65"
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    Permission granted by Aktiia
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    Q&A

    How Aktiia built the first over-the-counter cuffless blood pressure monitor

    Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.

    By Aug. 20, 2025
  • NeuroOne
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    Permission granted by NeuroOne
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    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.
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    Courtesy of CMR Surgical
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    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
  • 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.
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    Alamy
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    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.
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    Courtesy of Kardium
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    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.
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    Courtesy of Philips
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    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.
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    Andrew Harnik via Getty Images
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    Trump says semiconductor tariffs to come next week

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

    By Philip Neuffer • Aug. 15, 2025
  • Seven watches lined up side to side with different screens and colors.
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    Courtesy of Apple
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    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.
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    Permission granted by Reprieve Cardiovascular
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    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.
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    Courtesy of Vicarious Surgical
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    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
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    Permission granted by Johnson & Johnson
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    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
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    Stock via Getty Images
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    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"
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    Courtesy of Draeger
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    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
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    Courtesy of HeartFlow
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    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.
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    Stock via Getty Images
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    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.
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    Stock photo via Getty Images
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    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.
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    eranicle via Getty Images
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    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.
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    Courtesy of Tandem Diabetes Care
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    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.
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    Permission granted by Masimo
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    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.
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    Courtesy of Boston Scientific
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    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