Digital Health: Page 6

  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices

    The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.

    By • Oct. 19, 2023
  • tuberculosis scan
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    Spencer Platt via Getty Images
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    Siemens Healthineers partners to improve tuberculosis screening using AI

    The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.

    By • Oct. 18, 2023
  • the FDA Headquarters Explore the Trendline➔
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    Sara Silbiger via Getty Images
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
  • Three people sit on couches on a stage and one person speaks at a podium.
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    Elise Reuter/MedTech Dive
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    FDA to establish digital health advisory committee

    The agency is seeking advisers to help it understand the benefits, risks and outcomes associated with digital technologies.

    By • Oct. 12, 2023
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    Adobe Stock
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    AdvaMed elevates digital health center to division, names board

    The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.

    By • Oct. 10, 2023
  • A Samsung flag flies outside the Samsung office on August 25, 2017 in Seoul, South Korea.
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    Chung Sung-Jun via Getty Images
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    Samsung, b.well partner to collect health data on Galaxy smartphones

    Users will also be able to schedule appointments with select providers — including Walgreens, ThedaCare, Lee Health and Rise Health — through the Samsung Health app.

    By Emily Olsen • Oct. 10, 2023
  • Six people sit on a stage in front of a sign that says the MedTech Conference. A person in the center holds a microphone.
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    Elise Reuter/MedTech Dive
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    Clinicians ‘love yet fear’ AI, say medtech leaders

    Stryker, Siemens Healthineers and Google execs said at the MedTech Conference that digital technology can help with patient care, but healthcare professionals also worry about it taking their jobs.

    By • Oct. 10, 2023
  • Professional photo of Jan Makela
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    Permission granted by GE HealthCare
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    Q&A

    GE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership

    GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.

    By • Oct. 6, 2023
  • An X-ray image shows the lungs and the ribcage
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    the rads via Getty Images
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    Generative AI matches accuracy, quality of radiologist reports in study

    Artificial intelligence models could provide timely alerts and help with image interpretation in life-threatening situations, Northwestern University researchers said.

    By • Oct. 6, 2023
  • doctor on telehealth, telemedicine service analyzing online on EHR, EMR patient digita data on tablet in lab
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    Retrieved from Adobe Stock.
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    Duke researchers find app improves autism screening in NIH-funded study

    Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.

    By • Oct. 4, 2023
  • Illustration of graphic elements
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    Permission granted by Esper
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    Sponsored by Esper

    Healthtech companies dealing with complex device fleets, new report finds

    Four ways HealthTech companies are using modern solutions to manage their mission-critical devices.

    Oct. 2, 2023
  • A white, rectangular sticker device is in front of a blue, pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom

    Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom. 

    By • Sept. 25, 2023
  • Medical image of head scan
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    Shutterstock/sfam_photo

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    Sponsored by Shyft Global Services

    How can medical device OEMs support the circular economy?

    Discover how medical device OEMs can be part of the circular economy for a more sustainable future.

    Sept. 25, 2023
  • M&A
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    Nuthawut Somsuk via Getty Images
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    Is bigger better? McKinsey predicts the return of large medtech mergers

    The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.

    By • Sept. 22, 2023
  • U.S. Capitol In Washington
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    Stefan Zaklin via Getty Images
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    CMS leader defends breakthrough device reimbursement proposal at House hearing

    Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.

    By • Sept. 20, 2023
  • A person looks at a black and white image on a screen as they hold an ultrasound device to another person's chest.
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    peakSTOCK via Getty Images
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    Gates Foundation grants GE HealthCare $44M for AI ultrasound tech

    The money will go to subsidiary Caption Health to make AI tools to help with maternal care and pediatric lung health.

    By • Sept. 19, 2023
  • Young man unable to sleep during night at bedroom
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    Lakshmiprasad S via Getty Images
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    Beacon Biosignals receives FDA clearance for sleep tracking headband

    The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.

    By • Sept. 18, 2023
  • Front-facing view of an MRI machine with the words 'Signa Victor'
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    Courtesy of GE HealthCare
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    GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

    The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.

    By • Sept. 15, 2023
  • Akili's digital therapeutic, EndeavorRx, involves navigating obstacles in different courses. It's intended to improve attention.
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    Courtesy of Akili Interactive
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    Akili cuts 40% of workforce, plans shift to non-prescription model

    The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

    By • Sept. 13, 2023
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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    Study suggests AI could provide second reading of mammograms

    In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”

    By • Sept. 12, 2023
  • Intuitive Surgical's Tony Jarc is wearing a dark blue jacket and white shirt in a corporate head shot.
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    Permission granted by Intuitive Surgical
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    Q&A

    Intuitive’s Tony Jarc on how AI is improving robotic surgery

    The company aims to help surgeons achieve better results for patients and hospitals.

    By • Sept. 8, 2023
  • 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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    Microsoft, Paige team to use supercomputers to train cancer pathology AI models

    Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.

    By • Sept. 8, 2023
  • A phone app shows a chart with current glucose levels, next to a pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

    The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”

    By • Sept. 5, 2023
  • A black, square device with tubing connected to a patch is next to a phone that says "Beta Bionics" and another patch that says DexcomG6
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    Courtesy of Beta Bionics
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    Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market

    The company’s iLet Bionic Pancreas automates insulin dosing without requiring mealtime carb counting. 

    By • Sept. 1, 2023
  • A scale with three phone screens showing measurements including heart beats per minute and body composition.
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    Courtesy of Withings
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    Withings wins FDA clearance for scale with AFib detection

    The device records the electrical signal from the heart, assesses the number of calories the body burns at rest and tracks other health variables.

    By • Aug. 30, 2023
  • An anatomical heart is pictured in red in a transparent body.
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    magicmine via Getty Images
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    GE HealthCare rolls out software to speed assessment of AFib patients

    The program aims to cut the time physicians spend searching multiple systems to understand the cardiac history of AFib patients.

    By • Aug. 29, 2023