Digital Health

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    Courtesy of Aidoc
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    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
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    Permission granted by AAMI
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    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
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Courtesy of Apple
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    Apple fends off Masimo challenge to Apple Watch redesign

    Apple can continue selling redesigned Apple Watches with a blood oxygen feature after the International Trade Commission concluded the products do not infringe Masimo patents.

    By • April 22, 2026
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    Getty Images
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    Digital health funding concentrates in fewer startups: report

    Companies raised $4 billion in the first quarter, an increase of $1 billion over the prior year, according to Rock Health. But nearly 60% of the capital deployed came from 12 large deals.

    By Emily Olsen • April 8, 2026
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    Getty Images
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    ARPA-H launches program to develop biosensors that can track multiple signals

    The research initiative is part of a broader focus on wearables at the Department of Health and Human Services.

    By • March 10, 2026
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    Permission granted by Senseonics
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    Senseonics launches automated insulin dosing system with 1-year CGM

    The company has integrated its Eversense 365 implant with Sequel Med Tech’s insulin delivery system to automate the management of Type 1 diabetes. 

    By • Feb. 20, 2026
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    Courtesy of Apple
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    Apple Watch’s hypertension feature may miss some cases, researchers find

    The absence of an alert provides limited reassurance, particularly for older adults or people with an elevated risk of high blood pressure, according to the study’s authors. 

    By • Feb. 19, 2026
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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
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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
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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
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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