AI: Page 2

  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    CDRH shares regulatory guidance priorities for the coming 12 months

    Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.

    By • Oct. 2, 2025
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    Deep Dive

    AI could transform healthcare. Can safety-net providers keep up?

    Implementing artificial intelligence requires significant human labor and technical expertise, threatening to create a digital divide between highly resourced health systems and safety-net providers.

    By Emily Olsen • Oct. 2, 2025
  • Front sign of FDA building Explore the Trendline➔
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    Sarah Silbiger via Getty Images
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    Trendline

    AI tools are transforming the medtech space

    As artificial intelligence becomes more prominent in the medtech sector, the technology is changing what it means to be a medical device — and attracting top companies.

    By MedTech Dive staff
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    Alamy
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    FDA seeks feedback on monitoring real-world performance of AI devices

    The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.

    By • Oct. 1, 2025
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    Courtesy of HeartFlow
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    Heartflow receives FDA clearance for updated plaque analysis platform

    The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.

    By • Sept. 25, 2025
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    Courtesy of Aidoc
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    Deep Dive

    How three companies are using foundation models in radiology

    Some firms, such as Aidoc, are working directly with the FDA. Others, such as HOPPR, are offering their foundation models for medtech companies to build their own AI tools. 

    By • Sept. 16, 2025
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    Permission granted by Radiology Partners
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    Deep Dive

    Foundation models are medtech’s newest trend. But what are they?

    The AI models, which are built on massive datasets and can be adapted to multiple tasks, have become a part of medtech companies’ lexicon in the past few years.

    By • Sept. 15, 2025
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    Courtesy of Aidoc
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    AI drives medtech investment in 2025

    Medical device companies working with artificial intelligence raised funding and were acquisition targets in recent months.

    By • Sept. 12, 2025
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    Stringer via Getty Images
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    GE HealthCare inks Icometrix buyout to acquire brain MRI software

    The deal includes AI-powered software for detecting known side effects of recently launched Alzheimer’s drugs.

    By • Sept. 11, 2025
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    Permission granted by Ketryx
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    AI firm Ketryx raises $39M, adds former Medtronic CEO as investor

    The company, which helps medtech companies with AI compliance, has raised more than $55 million to date.

    By • Sept. 5, 2025
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    AI devices with no clinical validation tied to more recalls, study finds

    Public companies, which accounted for about half of AI-enabled devices on the market, had a higher rate of recalls and a lower rate of clinical evidence, according to a JAMA study.

    By • Sept. 2, 2025
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    Alamy
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    Medtech VC funding on track to hit highest value since 2021: PitchBook

    “Larger rounds increasingly favor top-tier companies and AI-native startups, leaving other startups fighting for a smaller pool of capital,” the firm said.

    By • Sept. 2, 2025
  • A pink stained tissue slide has a black circle with a crosshairs pointing to a segment of tissue and a patient's name and date of birth in the corner.
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    Courtesy of Paige
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    Tempus inks $81M Paige buyout to support AI model development

    CEO Eric Lefkofsky said that buying Paige “substantially accelerates” Tempus’ effort to build the largest foundation model in oncology.

    By • Aug. 26, 2025
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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
  • The Oracle logo on a building at an the technology company's campus on March 10, 2025 in Redwood Shores, California.
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    Justin Sullivan / Staff via Getty Images
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    Oracle launches AI-backed EHR

    The records system is available for U.S. ambulatory providers, pending regulatory approval. Oracle plans to launch in the acute care market next year.

    By Emily Olsen • Aug. 14, 2025
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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
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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
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    Cardiosense wins FDA clearance for wearable heart monitor

    The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.

    By • July 31, 2025
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    Health tech investment bolstered by AI in H1: report

    Venture capital investment across the healthcare sector slowed in the first half of the year, but investors are spending on health tech — especially artificial intelligence, according to a report by Silicon Valley Bank.

    By Emily Olsen • July 29, 2025
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    Roy Rochlin / Stringer via Getty Images
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    Trump administration releases AI adoption plan

    AdvaMed CEO Scott Whitaker said the medtech lobbying group looks forward to working on policies that will unleash “the full potential of AI to help make America healthy again.”

    By Emily Olsen • July 25, 2025
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    Courtesy of Aidoc
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    Aidoc raises $150M for AI foundation model

    The technology, called CARE, is expected to allow for faster development of AI models that can cover more health conditions.

    By • July 24, 2025
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    Alamy
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    Carlsmed seeks up to $103M IPO haul to fuel spine surgery growth

    The company’s custom implants compete with devices from Medtronic, Johnson & Johnson and Globus Medical.

    By • July 18, 2025
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    Permission granted by Amazon Web Services
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    Q&A

    Amazon’s Rowland Illing talks about AI’s shifting focus in medtech

    Amazon Web Services’ global chief medical officer said the healthcare industry is seeing an “absolute explosion” of generative AI use cases, with large models that can be adapted to a variety of tasks.

    By • July 10, 2025
  • A head shot of Martin Stumpe, Danaher's chief data and artificial intelligence officer.
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    Danaher appoints Martin Stumpe as chief technology and AI officer

    The company said Stumpe’s promotion is a “pivotal step in [its] digital transformation and its ambition to lead the next era of innovation in life sciences and diagnostics.”

    By • June 30, 2025
  • A wall bearing the Johnson & Johnson logo is seen outside of an office building.
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    Courtesy of Johnson & Johnson
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    J&J teams with Nvidia, Amazon on fund for AI surgery solutions

    J&J is offering up to $100,000 in grant funding, mentorship and access to computing capabilities.

    By • June 26, 2025
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    Joint Commission, CHAI partner to develop guidance on health AI

    The guidance should help health systems safely manage and monitor AI tools in a financially sustainable manner, which can be “a real challenge” for providers, said CHAI CEO Dr. Brian Anderson.

    By Emily Olsen • June 16, 2025