Digital Health: Page 5

  • Sanket Shah stands in front of a wood wall.
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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
  • Overhead view of brick, multistory buildings along a one-way street.
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    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
  • A union jack flag waves in the wind
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    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
  • A picture of Eko Health's stethoscope AI system.
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    Permission granted by Eko Health
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    Eko wins FDA nod for AI to detect sign of heart failure using stethoscope

    The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.

    By • April 4, 2024
  • Justin Barad wears scrubs and holds a VR headset
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    Permission granted by Osso VR
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    Osso VR to lay off 67 people at corporate HQ

    Art and illustration jobs were heavily affected by the layoffs, which will be complete by May 27.

    By • April 1, 2024
  • A picture of Sequel's Twiist automated insulin delivery system.
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    Courtesy of Sequel Med Tech
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    Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance

    Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.

    By • March 20, 2024
  • Header image for "77% of Companies Are Currently Undertaking or Considering Layoffs"
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    Getty Images
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    Better Therapeutics lays off staff, considers winding down business

    The digital therapeutics developer received authorization for a Type 2 diabetes treatment app last year but has struggled for money.

    By • March 15, 2024
  • Artificial intelligence helping businessman make strategy and forecast.
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    Getty Images
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    AI to expand medtech portfolios, revenue streams: Moody’s

    The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.

    By • March 12, 2024
  • Individuals look at an Apple Vision Pro headset.
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    Michael M. Santiago / Staff via Getty Images
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    Siemens Healthineers launches anatomy hologram app on Apple Vision Pro

    The prototype app has potential uses in patient communication, medical education and surgical planning.

    By • March 8, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche to take on Abbott, Dexcom with its first CGM

    The new sensor is designed to last for 14 days but requires finger-stick calibration.

    By • March 7, 2024
  • 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
  • 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