Digital Health

  • A picture of five Ōura smart rings against a gold background.
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    Courtesy of Ōura
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    FDA guidance eases wearables oversight. But experts have questions about what’s next.

    Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

    By • Jan. 27, 2026
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    AdvaMed leaders on tariffs, MDUFA and wearables

    AdvaMed CEO Scott Whitaker and Mick Farrell, new board chair of the trade group, weighed in on important issues for the medtech industry one year into the Trump administration.

    By • Jan. 22, 2026
  • A hand holding a smartphone displaying Amazon's Health AI assistant.
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    Courtesy of Amazon
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    Amazon launches health AI chatbot for One Medical members

    The assistant, which can answer health questions and help schedule appointments, comes on the heels of other health-focused AI tools from OpenAI and Anthropic.

    By Emily Olsen • Jan. 22, 2026
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    Getty Images
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    ECRI names misuse of AI chatbots as top health tech hazard for 2026

    The nonprofit said technologies like ChatGPT have suggested incorrect diagnoses, invented body parts and otherwise provided information that could lead to harm.

    By • Jan. 22, 2026
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    Getty Images
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    Digital health funding increases in 2025, spurred by AI: report

    Startups raised $14.2 billion last year, the highest funding total since 2022. Health AI companies collected 54% of total funding, according to Rock Health.

    By Emily Olsen • Jan. 15, 2026
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    Courtesy of Whoop
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    FDA exempts more wearable, AI features from oversight

    In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.

    By • Jan. 8, 2026
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    Permission granted by Oura
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    Q&A

    Ōura’s Ricky Bloomfield proposes new regulatory pathway for wearable health features

    The chief medical officer is interested in an easier path to market for health screening features in wearable devices.

    By • Jan. 5, 2026
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    Getty Images
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    FDA gets mixed feedback on performance monitoring for AI

    Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

    By • Dec. 16, 2025
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    Getty Images
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    FDA pilots allowing digital health devices access to CMS payment program

    Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

    By • Dec. 10, 2025
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    Courtesy of Whoop
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    Deep Dive

    What medtech firms can learn from Whoop’s warning letter

    An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.

    By • Dec. 8, 2025
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    Getty Images
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    Ceribell wins FDA clearance for seizure-detection algorithm in neonates

    By acquiring new accounts and expanding into NICUs managed by existing clients, Ceribell calculates it can unlock a $400 million market.

    By • Nov. 25, 2025
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    Getty Images
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    Health tech venture capital investment rebounds in 2025: report

    Funding through the third quarter surpassed last year’s total, according to PitchBook. Meanwhile, average deal sizes are skyrocketing as high valuations — especially for AI startups — drive larger rounds.

    By Emily Olsen • Nov. 24, 2025
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    Courtesy of Apple
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    Jury orders Apple to pay Masimo $634M in patent fight

    Apple said it plans to appeal the verdict, which could delay Masimo’s collection of the damages by as much as two years, one analyst said.

    By • Nov. 17, 2025
  • A picture of Synchron's brain-computer interface device against a white background.
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    Courtesy of Synchron
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    Synchron raises $200M to prepare for brain computer interface launch

    The company will use the money to accelerate pivotal trials and prepare for commercial launch of the Stentrode BCI system.

    By • Nov. 7, 2025
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    Mario Tama via Getty Images
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    J&J awards first grants from AI surgery fund

    Mayo Clinic and QAS.AI will receive funding and mentorship to help advance their projects.

    By • Oct. 27, 2025
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    Courtesy of MedTech Innovator
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    Profile

    Hemorrhage can be a serious problem after pregnancy. Here’s how one medtech founder is tackling it

    Kelsey Mayo, CEO of Armor Medical, received the grand prize in MedTech Innovator’s pitch competition for a wearable technology to detect serious blood loss early.

    By • Oct. 23, 2025
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    Courtesy of Oura
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    Ōura to pursue FDA clearance of blood pressure feature for smart ring

    The company has received approval to validate and define the feature in a study that is scheduled to start this year.

    By • Oct. 20, 2025
  • A picture of five Ōura smart rings against a gold background.
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    Courtesy of Ōura
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    Ōura raises $900M to develop new health features

    The investment values the smart-ring maker at $11 billion.

    By • Oct. 17, 2025
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    Elise Reuter/MedTech Dive, data from MedTech Dive
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    5 AI takeaways from AdvaMed’s conference

    Medical device firms discussed privacy, regulations and prioritizing projects as AI becomes more prevalent in the industry.

    By • Oct. 14, 2025
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    Getty Images
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    Digital health funding outpacing last year as huge rounds increase: report

    Investment in 2025 has reached $9.9 billion, exceeding the $8.4 billion that was raised through the third quarter last year, according to Rock Health.

    By Emily Olsen • Oct. 9, 2025
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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
  • A physician sits at the console of Medtronic's Hugo robotic surgery system.
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    Permission granted by Medtronic
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    Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status

    The Medtronic center will facilitate surgeon collaboration and AI-powered decision support. At Virtuoso Surgical, a robotic approach to bladder lesion removal is expected to improve precision.

    By • Sept. 24, 2025
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    Getty Images
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    Cardiosense names Eric Meizlish as CEO

    Cardiosense’s switch to a leader with experience scaling healthtech companies comes as it works to build on the recent 510(k) clearance of CardioTag.

    By • Updated Sept. 25, 2025
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    Sarah Silbiger via Getty Images
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    FDA warns on unauthorized blood pressure, infant monitoring devices

    Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

    By • Updated Sept. 18, 2025
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    Kayla Bartkowski via Getty Images
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    GOP bill extends telehealth flexibilities, sidesteps ACA subsidies

    The continuing resolution would fund the government, and preserve the flexibilities, through Nov. 21. But the bill makes no mention of extending more generous financial assistance for people who buy plans on the exchanges.

    By Emily Olsen • Sept. 17, 2025