Digital Health
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Synchron’s brain-computer interface tech meets safety goal
The six-patient trial also indicated the device worked, according to Synchron, with the conversion of brain signals to motor outputs allowing people to perform digital tasks.
By Nick Paul Taylor • Oct. 1, 2024 -
Remote patient monitoring in Medicare needs more oversight: OIG
Regulators say Medicare needs more data and oversight to avoid fraud and misuse. Digital health advocates argue the service is still crucial for managing chronic conditions.
By Emily Olsen • Sept. 27, 2024 -
Trendline
Medical 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 -
Medtronic, Siemens Healthineers partner on spine surgery
Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite.
By Elise Reuter • Sept. 25, 2024 -
Sponsored by Kalypso: A Rockwell Automation Business
AI’s growing influence on the medical device company’s value chain
Here are examples of how your MedTech organization can use AI across the product lifecycle.
Sept. 16, 2024 -
Apple wins FDA nod for hearing aid software for certain Airpods
Apple is the first company to receive authorization for over-the-counter hearing aid software.
By Nick Paul Taylor • Sept. 13, 2024 -
Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech
New over-the-counter sensors, an Abbott-Medtronic partnership and Roche’s first CGM are among diabetes technology’s top stories so far in 2024. Check out MedTech Dive’s roundup of the latest news.
By Ricky Zipp • Sept. 11, 2024 -
Apple adding sleep apnea feature to smartwatch
Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.
By Nick Paul Taylor • Sept. 10, 2024 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Deep Dive
Medtech 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 -
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 -
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 -
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 -
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 -
Q&A
ONC’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 -
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 -
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 -
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 -
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