Digital Health: Page 5

  • Professional photo of Marcus Schabacker in an office space.
    Image attribution tooltip
    Permission granted by ECRI
    Image attribution tooltip
    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
  • A picture of two people sitting at a table looking at a smart phone.
    Image attribution tooltip
    Retrieved from Dexcom on June 05, 2024
    Image attribution tooltip

    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
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline➔
    Image attribution tooltip
    Courtesy of Intuitive Surgical
    Image attribution tooltip
    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
  • A child plays EndeavorRx on a tablet. The digital therapeutic intended to improve attention in kids with ADHD.
    Image attribution tooltip
    Permission granted by Akili Interactive
    Image attribution tooltip

    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
  • Sanket Shah stands in front of a wood wall.
    Image attribution tooltip
    Permission granted by Otsuka Precision Health
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of H2O Therapeutics
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Tandem Diabetes Care
    Image attribution tooltip

    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
    Image attribution tooltip
    Justin Sullivan via Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Senseonics
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Exo
    Image attribution tooltip

    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.
    Image attribution tooltip
    Justin Sullivan/Getty Images via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Synchron
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Prenosis
    Image attribution tooltip

    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.
    Image attribution tooltip
    Permission granted by Eko Health
    Image attribution tooltip

    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
    Image attribution tooltip
    Permission granted by Osso VR
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Sequel Med Tech
    Image attribution tooltip

    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"
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Michael M. Santiago / Staff via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Courtesy of Roche
    Image attribution tooltip

    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
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    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
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    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.
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    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
    Image attribution tooltip
    Permission granted by Canary Medical
    Image attribution tooltip
    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