Digital Health

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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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    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
  • Roche Pharmaceutical Group's office building in Shanghai, China
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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
  • Masimo's Stork baby monitoring boot, smartphone app and camera are displayed.
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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
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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
  • ONC head Micky Tripathi stands behind a podium.
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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
  • Chiquita Brooks-LaSure speaks behind a podium in front of a black background.
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    Chip Somodevilla via Getty Images
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    Senators urge CMS to create AI payment pathway

    Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.

    By • June 18, 2024
  • A sign reading Food and Drug Administration is seen above a door to a government building.
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    Sarah Silbiger via Getty Images
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    FDA creates transparency principles for AI in medical devices

    The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.

    By • June 17, 2024
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    SDI Productions via Getty Images
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    Zimmer, RevelAi partner to sell AI tool for orthopedic care

    RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.

    By • Updated June 14, 2024
  • Professional photo of Marcus Schabacker in an office space.
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    Permission granted by ECRI
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    Q&A

    Stronger oversight of AI needed in medical devices, ECRI CEO says

    Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.

    By • June 5, 2024
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    Retrieved from Dexcom on June 05, 2024
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    Dexcom connects G7 CGM directly to Apple Watch in US

    Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.

    By • Updated June 7, 2024
  • A child plays EndeavorRx on a tablet. The digital therapeutic intended to improve attention in kids with ADHD.
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    Permission granted by Akili Interactive
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    Digital therapeutics firm Akili to sell for $34M

    Akili, which makes a video game treatment for ADHD, will merge with Virtual Therapeutics to create a larger digital health entity.

    By • May 30, 2024
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    Permission granted by Otsuka Precision Health
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    Otsuka defies digital health downturn with new company

    With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.

    By • May 29, 2024
  • A watch that says parky next to a smartphone, with another watch on the right.
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    Courtesy of H2O Therapeutics
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    FDA seeks AI tech to predict, detect Parkinson’s symptoms

    By testing artificial intelligence and machine learning models, the agency hopes to come up with best practices for Parkinson’s measures from wearables and smartphones.

    By • May 21, 2024
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    deberarr via Getty Images
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    FDA targets health inequality by improving at-home devices

    Michelle Tarver, an FDA official, said a new program is meant to advance health equity by considering people’s living conditions as part of medical device design.

    By • May 13, 2024
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
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    Courtesy of Tandem Diabetes Care
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    Tandem reports 224 injuries related to faulty insulin pump app

    A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.

    By • May 9, 2024
  • The latest Apple Watch will include entirely fiber-based packaging for the first time
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    Justin Sullivan via Getty Images
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    FDA qualifies Apple Watch AFib feature for use in clinical trials

    Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices. 

    By • May 6, 2024
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    Ramberg via Getty Images
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    UK sets out position on regulating AI as a medical device

    Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.

    By • May 3, 2024
  • A cylindrical device on the left with a wifi signal, next to a black rounded device and a smartphone showing a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics gets FDA clearance to pair CGM implant with insulin pumps

    Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.

    By • May 1, 2024
  • Exo's Iris handheld ultrasound probe is held to the chest of a patient.
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    Courtesy of Exo
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    Exo adds FDA-cleared AI tools to handheld ultrasound system

    Exo sees the new capabilities as especially helpful for healthcare providers in rural and under-resourced settings.

    By • April 25, 2024
  • A picture of the Apple Vision Pro headset at a conference event.
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    Justin Sullivan/Getty Images via Getty Images
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    Osso VR brings surgery training app to Apple Vision Pro

    Users can virtually walk through the steps of two orthopedic procedures: total knee replacement and carpal tunnel release.

    By • April 12, 2024
  • A metal, cylinder shaped hollow device has small electrodes around the sides.
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    Permission granted by Synchron
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    Synchron launches patient registry to prepare for brain implant trial

    The startup, which rivals Neuralink, is developing brain-computer interface technology that lets people control electronic devices hands-free.

    By • April 9, 2024
  • A screen shows the number "92" as a sepsis risk score, with "Very High Risk Category" at the top of the screen.
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    Permission granted by Prenosis
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    FDA grants de novo nod to AI tool for detecting sepsis

    Prenosis CEO Bobby Reddy Jr. told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.

    By • April 4, 2024