Digital Health
-
Leon Neal / Staff via Getty Images
4 takeaways from the FDA’s first digital health advisory committee
Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.
By Elise Reuter • Dec. 12, 2024 -
Just_Super via Getty Images
AI-enabled apps top ECRI’s list of health tech hazards in 2025
Other health tech hazards on ECRI’s annual list include the unmet technology support needs of home care patients, cybersecurity threats and substandard or fraudulent medical devices.
By Nick Paul Taylor • Dec. 9, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
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 -
Sarah Silbiger via Getty Images
FDA issues final guidance on postmarket updates to AI-enabled devices
By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.
By Elise Reuter • Dec. 4, 2024 -
Permission granted by Movano Health
Movano receives FDA nod for smart ring’s pulse oximeter feature
Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.
By Nick Paul Taylor • Dec. 3, 2024 -
Sittipol Sukuna via Getty Images
Sponsored by IFSThe power of composability: Overcoming field service management challenges in MedTech
Composable software seamlessly integrates with core systems, facilitating communication and real-time data sharing between diverse systems.
Dec. 2, 2024 -
Courtesy of Ōura
Dexcom invests $75M in Ōura, agrees to integrate smart rings and CGMs
The partnership will support data flows that enable people who use both companies’ devices to track how glucose levels affect other health metrics.
By Nick Paul Taylor • Nov. 20, 2024 -
bymuratdeniz via Getty Images
Sponsored by IFSTransforming MedTech innovation with complete asset and service lifecycle management
An effective lifecycle management strategy is essential, as the reliability and performance of these devices can be a matter of life and death.
Nov. 18, 2024 -
Courtesy of Tandem Diabetes Care
Tandem, Insulet tout Type 2 expectations as tech attracts new users
Insulet saw strong insulin pump adoption among new users with Type 2 diabetes following its recent FDA clearance, while Tandem plans to file a Type 2 submission by year’s end.
By Ricky Zipp • Nov. 8, 2024 -
Permission granted by Johnson & Johnson
J&J Medtech CIO Larry Jones resigns
Jones, who has led connectivity solutions for J&J’s surgical robots, announced his departure on LinkedIn.
By Elise Reuter • Updated Nov. 1, 2024 -
Emily Olsen/MedTech Dive
Deep DiveTech companies pitch AI platforms for healthcare, outline plans for responsible rollout
Google, Microsoft and GE Healthcare say they’ll power the next wave of AI advancement. But executives are split on how to offer the tools to providers responsibly — and whether all clinicians are equally ready for them.
By Susanna Vogel • Nov. 1, 2024 -
Emily Olsen/MedTech Dive
Health startups need consolidation after pandemic funding ‘sugar high’
M&A could allow startups to add products and capabilities in a more restrained funding environment, panelists said at HLTH.
By Emily Olsen • Oct. 24, 2024 -
Permission granted by GE Healthcare
GE Healthcare opens AI Innovation Lab to grow new projects
The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.
By Nick Paul Taylor • Oct. 22, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceFDA, Health Canada give sneak peek into future AI regs
Canada’s device agency plans to issue guidance on machine learning, and the FDA plans to release a draft guidance next year on lifecycle management and premarket submissions for AI devices.
By Elise Reuter • Oct. 16, 2024 -
erdikocak via Getty Images
Digital health deal count declines in Q3, but check sizes stabilize: Rock Health
Startups notched 110 deals in the third quarter, compared with 133 in the second quarter. But average deal size held steady, suggesting investors are making “fewer, more focused bets,” according to the consultancy firm.
By Emily Olsen • Oct. 14, 2024 -
Daniel Karmann/Picture-Alliance/DPA/AP
Deep DiveThe number of AI medical devices has spiked in the past decade
The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.
By Elise Reuter , Jasmine Ye Han • Oct. 9, 2024 -
Courtesy of Synchron
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 -
SolStock via Getty Images
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 -
Courtesy of Siemens Healthineers
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 -
AdobeStock/metamorworks
Sponsored by Kalypso: A Rockwell Automation BusinessAI’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 -
Scott Olson via Getty Images
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 -
Permission granted by Abbott
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 -
Justin Sullivan via Getty Images
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 -
the rads via Getty Images
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 -
andresr via Getty Images
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 -
Win McNamee/Getty Images via Getty Images
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
