Digital Health

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    Elise Reuter/MedTech Dive
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    The Medtech Conference

    FDA, Health Canada give sneak peek into future AI regs

    Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.

    By • Oct. 16, 2024
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    erdikocak via Getty Images
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    Digital health deal count declines in Q3, but check sizes stabilize: Rock Health

    Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to the consultancy firm.

    By Emily Olsen • Oct. 14, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Daniel Karmann/Picture-Alliance/DPA/AP

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    Deep Dive

    The number of AI medical devices has spiked in the past decade

    The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.

    By , • Oct. 9, 2024
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    Courtesy of Synchron
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    Synchron’s brain-computer interface tech meets safety goal

    The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.

    By • Oct. 1, 2024
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    SolStock via Getty Images
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    Remote patient monitoring in Medicare needs more oversight: OIG

    Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.

    By Emily Olsen • Sept. 27, 2024
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    Courtesy of Siemens Healthineers
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    Medtronic, Siemens Healthineers partner on spine surgery

    Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.

    By • Sept. 25, 2024
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    AdobeStock/metamorworks

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    Sponsored by Kalypso: A Rockwell Automation Business

    AI’s growing influence on the medical device company’s value chain

    Here are examples of how your MedTech organization can use AI across the product lifecycle.

    Sept. 16, 2024
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    Scott Olson via Getty Images
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    Apple wins FDA nod for hearing aid software for certain Airpods

    Apple is the first company to receive authorization for over-the-counter hearing aid software.

    By • Sept. 13, 2024
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    Permission granted by Abbott
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    Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech

    New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.

    By • Sept. 11, 2024
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    Justin Sullivan via Getty Images
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    Apple adding sleep apnea feature to smartwatch

    Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.

    By • Sept. 10, 2024
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    the rads via Getty Images
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    Many FDA-authorized AI devices lack validation data

    About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.

    By • Sept. 9, 2024
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    andresr via Getty Images
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    AI still the most exciting emerging technology for healthcare: survey

    AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.

    By Emily Olsen • Sept. 4, 2024
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    Win McNamee/Getty Images via Getty Images
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    ARPA-H program to focus on AI degradation in medical tools

    The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.

    By • Sept. 3, 2024
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    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
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    Retrieved from Otsuka Precision Health on August 14, 2024
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    Otsuka Precision Health launches first digital therapeutic for depression

    Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.

    By • Aug. 14, 2024
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    Retrieved from Care.ai on August 12, 2024
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    Stryker to buy smart hospital technology firm Care.ai

    The deal comes shortly after Stryker CEO Kevin Lobo told investors to expect a “very active deal pipeline” for the second half of 2024.

    By • Aug. 12, 2024
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    Sarah Silbiger via Getty Images
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    FDA officials outline benefits of AI lifecycle management

    The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.

    By • July 30, 2024
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    Spencer Platt via Getty Images
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    AI’s expert-level image analysis can be built on flawed rationales: study

    Researchers at the National Institutes of Health found that a version of ChatGPT analyzed images at an expert level but frequently reached the right answer with incorrect reasoning.

    By • July 25, 2024
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    Ryan David Brown/Getty Images via Getty Images
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    Deep Dive

    Medtech firms have cut more than 14,000 jobs in the past 18 months

    Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.

    By , , • Updated July 25, 2024
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    iStock via Getty Images
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    Roche wins CE mark for its first CGM

    The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.

    By • Updated July 10, 2024
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    Courtesy of Masimo
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    Masimo offered up to $950M for consumer business

    Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.

    By • July 9, 2024
  • A picture of a man looking at a diabetes tracking app on his phone.
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    Retrieved from Ascensia Diabetes Care on June 25, 2024
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    Senseonics tips 365-day CGM to double 2025 sales

    Senseonics is in talks with insulin pump manufacturers about integrating its implantable Eversense continuous glucose monitor with their devices.

    By • June 25, 2024
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    Mario Tama via Getty Images
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    J&J creates open digital platform for surgical applications

    J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.

    By • June 21, 2024
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    Courtesy of HHS
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    Q&A

    ONC’s Micky Tripathi on laying the digital floor for healthcare AI

    The agency head discussed ONC’s accomplishments over the past two decades, artificial intelligence opportunities and improving the documentation burden among clinicians.

    By Emily Olsen • June 20, 2024
  • The headquarters of the FDA, which has recently issued a recall for Teleflex air filters used in hospital respirators.
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    Sarah Silbiger/Getty Images via Getty Images
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    FDA official sets out approach to AI in medical devices

    Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.

    By • June 18, 2024