Digital Health: Page 4
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Courtesy of Exo
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 Nick Paul Taylor • April 25, 2024 -
Justin Sullivan/Getty Images via Getty Images
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 Nick Paul Taylor • April 12, 2024 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 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 -
Permission granted by Synchron
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 Elise Reuter • April 9, 2024 -
Permission granted by Prenosis
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 Elise Reuter • April 4, 2024 -
Permission granted by Eko Health
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 Nick Paul Taylor • April 4, 2024 -
Permission granted by Osso VR
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 Nick Paul Taylor • April 1, 2024 -
Courtesy of Sequel Med Tech
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 Nick Paul Taylor • March 20, 2024 -
Getty Images via Getty Images
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 Nick Paul Taylor • March 15, 2024 -
zhuweiyi49 via Getty Images
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 Nick Paul Taylor • March 12, 2024 -
Michael M. Santiago / Staff via Getty Images
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 Nick Paul Taylor • March 8, 2024 -
Courtesy of Roche
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 Nick Paul Taylor • March 7, 2024 -
Courtesy of Dexcom
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 Nick Paul Taylor • March 4, 2024 -
Sara Silbiger via Getty Images
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 Nick Paul Taylor • Feb. 23, 2024 -
Flashvector via Getty Images
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 Nick Paul Taylor • Feb. 21, 2024 -
Permission granted by Canary Medical
Q&ACanary 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 Elise Reuter • Feb. 15, 2024 -
Courtesy of Samsung Electronics
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 Nick Paul Taylor • Feb. 14, 2024 -
iStock / Sean Anthony Eddy
Sponsored by Veeva MedTechUnifying 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 -
Courtesy of BD
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 Nick Paul Taylor • Feb. 1, 2024 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • Jan. 31, 2024 -
Sascha Steinbach via Getty Images
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 Susan Kelly • Jan. 26, 2024 -
Sara Silbiger via Getty Images
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 Nick Paul Taylor • Jan. 25, 2024 -
Justin Sullivan via Getty Images
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 Susan Kelly • Jan. 18, 2024 -
Courtesy of Dermasensor
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 Nick Paul Taylor • Updated Jan. 22, 2024 -
Kobus Louw via Getty Images
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 Nick Paul Taylor • Jan. 16, 2024 -
Eric Thayer via Getty Images
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 Susan Kelly • Jan. 16, 2024
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