Digital Health: Page 5

  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
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    Courtesy of Dexcom
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    Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices

    The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.

    By • March 4, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    FDA warns against using smart wearables that claim to measure blood sugar

    Unauthorized smartwatches and smart rings are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency.

    By • Feb. 23, 2024
  • 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
  • Cartoon hand that is holding a smartphone with a health application.
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    Getty Images
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    Better Therapeutics wins breakthrough status for health app to treat liver disease

    The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.

    By • Feb. 21, 2024
  • Portrait of Bill Hunter
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    Permission granted by Canary Medical
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    Q&A

    Canary CEO Bill Hunter talks smart knee implant progress, new heart device

    The company collaborated with Zimmer Biomet on its Persona IQ device, which is slated for a full market release this year. Canary is also working on an implantable monitor for heart failure patients.

    By • Feb. 15, 2024
  • Close up of a watch on a person's wrist that says "sleep apnea 10:17 am"
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    Courtesy of Samsung Electronics
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    Samsung wins de novo nod for watch that detects sleep apnea

    The FDA created special controls that provide a path to market for other developers of over-the-counter devices.

    By • Feb. 14, 2024
  • Medical scientists analyzing research scans on a computer
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    iStock / Sean Anthony Eddy

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    Sponsored by Veeva MedTech

    Unifying EDC to Address Protocols and Various Data Sources Perspectives from Alcon and Illumina

    Alcon and Illumina clinical leaders share insights on their digital clinical transformations, including challenges, implementation best practices, and outcomes including speeding study builds, reducing manual effort, and ensuring audit readiness.

    Feb. 5, 2024
  • With the digital cervical cytology system, the samples can be scanned, converted to a digital slide image, and then reviewed on a computer monitor in a lab or from a remote location.
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    Courtesy of BD
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    BD partners with Techcyte to offer AI-enhanced cervical cancer screening

    Techcyte has developed a system to reduce the amount of cells pathologists need to review.

    By • Feb. 1, 2024
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA extends deadline for comments on role of digital health in diabetes detection

    The agency is seeking answers on how digital health technologies could be used in the detection of prediabetes and Type 2 diabetes.

    By • Jan. 31, 2024
  • A green leaf on top of a white Apple logo outside a glass building at night.
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    Sascha Steinbach via Getty Images
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    How Masimo forced Apple to redesign its smartwatches

    In a long-running patent dispute, Masimo has compelled the tech giant to remove the pulse oximetry function of certain Apple Watches.

    By • Jan. 26, 2024
  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain

    The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.

    By • Jan. 25, 2024
  • Three watches stand on display with digital screens.
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    Justin Sullivan via Getty Images
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    Apple to sell watches without pulse oximetry after ban of original design takes effect

    A court Wednesday denied Apple’s request for an extended stay on an import ban of its smartwatches, after the International Trade Commission found the products infringed Masimo’s patents.

    By • Jan. 18, 2024
  • Dermasensor's real-time, non-invasive skin cancer evaluation system.
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    Courtesy of Dermasensor
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    Dermasensor wins FDA clearance for AI-enabled skin cancer detection device

    A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians.

    By • Updated Jan. 22, 2024
  • Glasses, coding and reflection with business man reading software development analytics, database and system error report for information technology.
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    Getty Images
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    EssilorLuxottica integrates tech into glasses to target hearing loss market

    The glasses feature microphones, speakers and algorithms to amplify speech, but the technology is hidden in the frame.

    By • Jan. 16, 2024
  • Appl
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    Getty Images
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    Apple, locked in patent fight with Masimo, redesigns smartwatch

    The tech giant could bring to market watches without a pulse oximetry feature to avoid an ITC ban on sales of versions now on the market.

    By • Jan. 16, 2024
  • Masimo's W1 health watch
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    Courtesy of Masimo
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    Masimo’s preliminary Q4 results, 2024 outlook exceed analyst expectations

    Analysts see the update as evidence Masimo may be rebounding after failing to meet their expectations earlier in the year.

    By • Jan. 11, 2024
  • Sunny Kumar
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    Permission granted by GSR Ventures
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    Q&A

    ‘Healthy pullback’: GSR Ventures’ Sunny Kumar on normalizing digital health funding, accelerating M&A in 2024

    Sunny Kumar discusses digital healthcare investment, the landscape for M&A and when the public markets could open back up. 

    By Emily Olsen • Jan. 8, 2024
  • doctor talking to people
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    Getty Images
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    Sponsored by Nuance

    The power of generative AI in healthcare: Unmasking 5 key factors beyond the hype

    With hundreds of startups emerging in the healthcare AI market, here are the five factors every clinical and business leader should consider when assessing a generative AI solution and vendor.

    By Rebecca Schechter | Senior Vice President & General Manager, Dragon Ambient eXperience (DAX) • Jan. 8, 2024
  • Clinical investigators review cardiopulmonary assessments by Nanowear’s Simplesense device.
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    Permission granted by Nanowear
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    Nanowear gets FDA clearance for undergarment that estimates blood pressure

    The company’s continuous blood pressure monitor allows clinical investigators to remotely capture data on patients.

    By • Jan. 5, 2024
  • Three watches stand on display with digital screens.
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    Justin Sullivan via Getty Images
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    Apple Watch sales resume after latest twist in Masimo patent case

    An appeals court has granted Apple’s emergency motion to pause the U.S. International Trade Commission’s ban on sales of its watches with a pulse oximetry feature.

    By • Jan. 3, 2024
  • A man standing in front of a black background with the outline of the Apple logo
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    Justin Sullivan via Getty Images
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    Apple to pause US sales of smartwatches with pulse oximetry

    The tech giant’s move follows a USITC ruling that found the watches infringed some of Masimo's patents for measuring blood oxygen.

    By • Dec. 20, 2023
  • A person types on a computer with a stethoscope in the background.
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    Courtesy of Tandem Diabetes Care
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    Tandem completes US launch of revamped diabetes management platform

    The platform, Tandem Source, combines the features of the company’s legacy t:connect offerings with new data reports.

    By • Dec. 15, 2023
  • A rectangular box with arrows on the front says "Medtronic GI Genius"
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    Permission granted by Medtronic
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    Medtronic expands AI endoscopy partnership with Cosmo

    The collaboration will focus on Cosmo Intelligent Medical Devices’ GI Genius module, which Medtronic distributes globally.

    By • Dec. 11, 2023
  • Nick Jonas, Dexcom
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    Courtesy of Dexcom, Nick Jonas Super Bowl kit
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    Dexcom, Hologic picked to outperform in 2024: William Blair

    For the medtech industry overall, the analysts wrote that procedure volume growth is likely to normalize after declining due to the COVID-19 pandemic.

    By • Dec. 7, 2023
  • Murielle Thinard McLane, managing partner and head of Intuitive Ventures
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    Courtesy of Intuitive Ventures
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    Intuitive’s venture capital arm launches second investment fund

    The $150 million fund will back early-stage companies focused on healthcare access, digital health, and precision diagnostics and interventions.

    By • Dec. 5, 2023
  • A Resmed sleep apnea machine
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    Courtesy of ResMed
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    Resmed’s new C-suite focused on growing sleep apnea device demand: analysts

    After gaining market share during the Philips recall, Resmed can keep growing by stimulating demand through marketing initiatives and new products, William Blair analysts wrote.

    By • Dec. 4, 2023