AI

  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Vara receives CE mark for first autonomous breast cancer screening

    The AI-enabled device can report screenings it determines are normal without radiologist review.

    By • Sept. 4, 2026
  • A man wearing a white shirt and grey pants stands in front of a robotice blood drawing machine.
    Image attribution tooltip
    Courtesy of Vitestro
    Image attribution tooltip

    Vitestro secures FDA nod for robotic blood draw device

    The Food and Drug Administration hailed the potential of the first-of-its-kind device to counter the U.S. phlebotomist shortage. 

    By • Aug. 20, 2026
  • Three components of Johnson & Johnson's Ottava robotic surgery system are displayed. Explore the Trendline➔
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    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 sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    FDA seeks feedback on generative AI regulations

    The agency published a discussion paper this week as it considers the “unique risks” and potential promise of generative AI for patient care.

    By • Aug. 19, 2026
  • A person holds out their arm with a blood pressure cuff wrapped around it while another person inflates it.
    Image attribution tooltip
    Joe Raedle via Getty Images
    Image attribution tooltip

    FDA names second participant in TEMPO digital health pilot

    Cadence, a company that makes AI-enabled software to support hypertension management, will join the pilot, which allows companies to collect real-world data through Medicare.

    By • Aug. 17, 2026
  • Medical professionals reviewing diagnostic imaging.
    Image attribution tooltip
    gorodenkoff via Getty Images
    Image attribution tooltip
    Sponsored by Dell Technologies & NVIDIA

    From the clinic to the community: advancing healthcare innovation

    See how Dell and NVIDIA are bringing AI-powered solutions to every point of care.

    By Sandra Colner • Aug. 17, 2026
  • a padlock inside a hexagon
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    CHAI creates work group to counter frontier AI model cybersecurity risks

    CHAI plans to create playbooks to help organizations defend against — and leverage — these powerful systems.

    By Jill Hughes • Aug. 14, 2026
  • A portrait of George Murgatroyd.
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip
    Q&A

    Medtronic on the future of AI-assisted surgery

    Medtronic’s George Murgatroyd says an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.

    By • Aug. 5, 2026
  • Caristo Diagnostics' CaRi-Heart technology shown on a screen.
    Image attribution tooltip
    Permission granted by Caristo Diagnostics
    Image attribution tooltip

    Caristo wins FDA authorization for cardiovascular risk predictor

    The University of Oxford spinout will soon launch the AI tool, which research suggests could help assess heart attack risk in patients who don’t have obstructive coronary artery disease.

    By • Aug. 4, 2026
  • Images on the left side of a screen show tissue from a breast ultrasound, while the right screen shows a radiologist report with findings written out.
    Image attribution tooltip
    Courtesy of DeepHealth
    Image attribution tooltip

    DeepHealth gets FDA nod for AI tool that reads ultrasounds, creates reports

    DeepHealth’s tool automates lesion detection, characterization and reporting from breast ultrasound scans.

    By • Aug. 4, 2026
  • A person in a lab coat is seen through a well-lit, organized laboratory environment featuring shelves stocked with additional lab supplies and instruments.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    The FDA was all in on AI. Will that change?

    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

    By Kelly Bilodeau • July 29, 2026
  • An X-ray image shows the lungs and the ribcage
    Image attribution tooltip
    Getty Images
    Image attribution tooltip
    Q&A

    Why Aidoc is taking a generative AI device to the FDA

    Aidoc is bringing a system that can interpret images and make draft reports for radiologists to the FDA as the medtech industry awaits clarity on regulation of generative AI. Ensuring safety is paramount, said CEO Elad Walach.

    By • July 27, 2026
  • A surgeon sits at the Hugo robot console while another clinician attends to a patient on an operating table.
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic adds real-time AI to Hugo robot

    The computing platform will make its debut at the Society of Robotic Surgery meeting this week, as Medtronic challenges Intuitive in the U.S. robotic soft tissue market.

    By • July 21, 2026
  • Boston Scientific's headquarters building is shown.
    Image attribution tooltip
    Courtesy of Boston Scientific
    Image attribution tooltip

    Top 10 medtech deals in the first half of 2026

    Boston Scientific, Medtronic and Stryker were among the companies to ink deals to move into markets that are expanding quickly.

    By • July 6, 2026
  • A metal freestanding sign that reads, "Mary E Switzer Building, 330 C Street, SW, U.S. Department of Health and Human Services, Entrance" is surrounded by a brush with a building in the background.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    HHS details takeaways from sweeping AI request for information

    The healthcare sector wants the HHS to coordinate its AI strategy across agencies, provide implementation and governance support, and offer help in evaluating AI tools, leaders said Thursday.

    By Emily Olsen • June 29, 2026
  • An X-ray image shows the lungs and the ribcage
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Aidoc wins breakthrough nod for AI that reads chest X-rays

    Aidoc is working on an artificial intelligence feature that would analyze chest X-rays and generate preliminary reports for more than 100 findings.

    By • June 26, 2026
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip
    Q&A

    BD’s Bilal Muhsin talks AI in connected care

    Muhsin discussed how BD is rolling out a new medication dispenser and a software platform that pulls together data from the company’s various devices.

    By • Updated June 25, 2026
  • Medtronic's Stealth AXiS system.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic set for Stealth AXiS expansion in Europe

    With the CE mark for ear, nose and throat procedures, the advanced surgical navigation platform will be available to more surgeons across the region.

    By • June 9, 2026
  • Healthcare professional using stethoscope to examine senior patient's chest
    Image attribution tooltip
    SDI Productions via Getty Images
    Image attribution tooltip
    Sponsored by Infineon Technologies and Eko Health

    Reinventing the stethoscope and cardiopulmonary care

    AI-powered smart stethoscopes are making early disease detection easier than ever.

    May 18, 2026
  • Scientific illustration of a migrating breast cancer cell
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Artera gets FDA clearance for AI breast cancer risk prediction tool

    The company launched in 2023 with $90 million in funding from organizations including Johnson & Johnson’s venture capital arm.

    By • May 12, 2026
  • A person points to a large screen showing vital signs.
    Image attribution tooltip
    Permission granted by Will Kirk / Johns Hopkins University
    Image attribution tooltip

    Bayesian Health gets FDA nod for AI sepsis detection tool

    Created by Johns Hopkins University researchers, the early warning system for sepsis aims to help physicians detect the serious condition earlier.

    By • May 12, 2026
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    Abbott gets FDA nod, CE mark for AI-enabled imaging device

    The device joins a portfolio of vascular technologies that generated 9.5% sales growth on a comparable basis in the first quarter.

    By • May 4, 2026
  • A person points to a scan on a screen.
    Image attribution tooltip
    Courtesy of Aidoc
    Image attribution tooltip

    Aidoc raises $150M to advance clinical AI foundation model

    The company wants AI to support all complex diagnostic decisions by 2030 to prevent diagnostic errors and delays.

    By • May 1, 2026
  • Medtronic's Stealth AXiS system.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    Medtronic secures CE mark for Stealth AXiS surgical system

    Receiving the clearance positions Medtronic to launch a product that combines surgical planning, navigation and robotics in Europe.

    By • April 29, 2026
  • Money Puzzle - stock photo
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    AcuityMD raises $80M to add AI capabilities to medtech sales software

    The company plans to introduce AI agents for personas such as sales reps, leadership and marketing teams.

    By • April 23, 2026
  • A person stands behind a podium and speaks.
    Image attribution tooltip
    Permission granted by AAMI
    Image attribution tooltip

    CDRH Director Tarver previews AI guidance at AAMI event

    Michelle Tarver said the device center plans to finalize guidance on AI lifecycle management and provide some initial thoughts on generative AI following an advisory committee meeting last year.

    By • April 22, 2026