Digital Health: Page 2
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Many FDA-authorized AI devices lack validation data
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
By Elise Reuter • Sept. 9, 2024 -
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AI still the most exciting emerging technology for healthcare: survey
AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.
By Emily Olsen • Sept. 4, 2024 -
Explore the Trendline➔
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
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ARPA-H program to focus on AI degradation in medical tools
The agency will fund work to identify and auto-correct AI-enabled tools that are misaligned with their underlying training data.
By Nick Paul Taylor • Sept. 3, 2024 -
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Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator
The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.
By Emily Olsen • Aug. 29, 2024 -
Retrieved from Otsuka Precision Health on August 14, 2024
Otsuka Precision Health launches first digital therapeutic for depression
Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.
By Elise Reuter • Aug. 14, 2024 -
Retrieved from Care.ai on August 12, 2024
Stryker to buy smart hospital technology firm Care.ai
The deal comes shortly after Stryker CEO Kevin Lobo told investors to expect a “very active deal pipeline” for the second half of 2024.
By Elise Reuter • Aug. 12, 2024 -
Sarah Silbiger via Getty Images
FDA officials outline benefits of AI lifecycle management
The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.
By Nick Paul Taylor • July 30, 2024 -
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AI’s expert-level image analysis can be built on flawed rationales: study
Researchers at the National Institutes of Health found that a version of ChatGPT analyzed images at an expert level but frequently reached the right answer with incorrect reasoning.
By Nick Paul Taylor • July 25, 2024 -
Ryan David Brown/Getty Images via Getty Images
Deep DiveMedtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
By Jasmine Ye Han , Ricky Zipp , Elise Reuter • Updated July 25, 2024 -
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Roche wins CE mark for its first CGM
The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.
By Nick Paul Taylor • Updated July 10, 2024 -
Courtesy of Masimo
Masimo offered up to $950M for consumer business
Final terms of the deal are still being discussed, and Masimo said it plans to negotiate a higher price.
By Nick Paul Taylor • July 9, 2024 -
Retrieved from Ascensia Diabetes Care on June 25, 2024
Senseonics tips 365-day CGM to double 2025 sales
Senseonics is in talks with insulin pump manufacturers about integrating its implantable Eversense continuous glucose monitor with their devices.
By Nick Paul Taylor • June 25, 2024 -
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J&J creates open digital platform for surgical applications
J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.
By Nick Paul Taylor • June 21, 2024 -
Courtesy of HHS
Q&AONC’s Micky Tripathi on laying the digital floor for healthcare AI
The agency head discussed ONC’s accomplishments over the past two decades, artificial intelligence opportunities and improving the documentation burden among clinicians.
By Emily Olsen • June 20, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA official sets out approach to AI in medical devices
Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.
By Elise Reuter • June 18, 2024 -
Chip Somodevilla via Getty Images
Senators urge CMS to create AI payment pathway
Uniform reimbursement standards are needed to protect patient access to algorithm-based devices and ensure future innovation, the lawmakers said.
By Nick Paul Taylor • June 18, 2024 -
Sarah Silbiger via Getty Images
FDA creates transparency principles for AI in medical devices
The agency worked with regulators in the U.K. and Canada to determine how key information about machine learning-enabled devices should be communicated.
By Nick Paul Taylor • June 17, 2024 -
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Zimmer, RevelAi partner to sell AI tool for orthopedic care
RevelAi uses generative artificial intelligence to automate clinical workflows and support patients with conditions such as osteoarthritis.
By Nick Paul Taylor • Updated June 14, 2024 -
Permission granted by ECRI
Q&AStronger 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 Elise Reuter • June 5, 2024 -
Retrieved from Dexcom on June 05, 2024
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 Nick Paul Taylor • Updated June 7, 2024 -
Permission granted by Akili Interactive
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 Elise Reuter • May 30, 2024 -
Permission granted by Otsuka Precision Health
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 Elise Reuter • May 29, 2024 -
Courtesy of H2O Therapeutics
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 Elise Reuter • May 21, 2024 -
deberarr via Getty Images
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 Elise Reuter • May 13, 2024 -
Courtesy of Tandem Diabetes Care
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 Nick Paul Taylor • May 9, 2024
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