AI
-
Permission granted by CMR Surgical
Robots, AI and PFA: The top medtech Q&As of 2024
From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.
By Ricky Zipp • Dec. 20, 2024 -
Courtesy of Dexcom
Dexcom adds generative AI to over-the-counter CGMs
Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.
By Elise Reuter • Dec. 18, 2024 -
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 -
Retrieved from Cleerly on December 06, 2024
Cleerly raises $106M to fund AI-driven heart disease tool
The company has generated evidence that shows its system is better than experts at assessing vessel narrowing, plaque volume and composition.
By Nick Paul Taylor • Dec. 6, 2024 -
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 -
Spencer Platt/Getty Images via Getty Images
Medtronic wins VA contract to install AI-powered endoscopy units
The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. centers.
By Nick Paul Taylor • Nov. 26, 2024 -
Courtesy of Medtronic
Medtronic, Tempus testing AI to find potential TAVR patients
The randomized trial will use Tempus’ platform to find patients who are eligible for interventions such as TAVR but do not have a treatment plan in place.
By Nick Paul Taylor • Nov. 25, 2024 -
SDI Productions via Getty Images
Health systems band together to test and publicly rank top AI models
Mass General Brigham, Emory and other providers will assess different AI models from companies like Google, Microsoft and Amazon.
By Susanna Vogel • Nov. 18, 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 GE Healthcare
GE Healthcare inks AI mammography pact with Radnet
The alliance positions GE Healthcare to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow.
By Nick Paul Taylor • Nov. 12, 2024 -
Courtesy of Ambry Genetics
Tempus AI to buy genetic testing company for $600M
CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.
By Elise Reuter • Nov. 6, 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
Deep DiveAI could be a game changer, but healthcare needs to be ‘exceedingly careful’
Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.
By Emily Olsen • Oct. 29, 2024 -
Emily Olsen/MedTech Dive
Thoughtful implementation, ongoing monitoring key to safe health AI
Healthcare organizations will need to test models in their local environments, keep an eye on performance and work together to implement the technology, panelists said at HLTH.
By Emily Olsen • Oct. 28, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceMedtech Conference recap: New CDRH leader details approach; AI and LDTs in focus
Catch up on our recent coverage of Advamed’s The Medtech Conference.
By Elise Reuter • Oct. 23, 2024 -
Elise Reuter/MedTech Dive
The Medtech ConferenceThat’s a wrap: 5 takeaways from The Medtech Conference
The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.
By Elise Reuter • Oct. 22, 2024 -
Sarah Silbiger via Getty Images
FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Win McNamee via Getty Images
Health officials outline industry role in AI oversight in JAMA article
FDA Commissioner Robert Califf and two colleagues warned that the “scale of effort” needed to repeatedly evaluate AI models “could be beyond any current regulatory scheme.”
By Nick Paul Taylor • Oct. 16, 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 -
Courtesy of Metro Toronto Convention Centre
The Medtech Conference4 trends to watch at Advamed’s The Medtech Conference
As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.
By Elise Reuter • 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 -
Nuthawut Somsuk via Getty Images
Mendaera raises $73M to develop handheld robotics platform
Fred Moll, founder of surgical robotics firms Intuitive Surgical and Auris Health, participated in in the financing round, along with previous Auris investors.
By Nick Paul Taylor • Sept. 27, 2024 -
Justin Sullivan/Staff via Getty Images
Advamed backs FDA’s misinformation draft, calls for updates on AI and deep fakes
Advamed said the draft guidance “better reflects the wide scope of internet-based content seen in today’s information age” than an earlier version.
By Nick Paul Taylor • Sept. 16, 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
