AI
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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 -
Sponsored by IFS
Transforming 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 -
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 -
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 -
Deep Dive
Tech 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 -
Deep Dive
AI 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 -
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 -
The Medtech Conference
Medtech 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 -
The Medtech Conference
That’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 -
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 -
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 -
The Medtech Conference
FDA, 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 -
The Medtech Conference
4 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 -
Deep Dive
The 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 -
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 -
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 -
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 -
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 -
Q&A
‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
By Susan Kelly • July 22, 2024 -
GE Healthcare to buy AI software from Intelligent Ultrasound for $51M
After purchasing Caption Health last year, GE Healthcare plans to add another artificial intelligence acquisition to the company.
By Nick Paul Taylor • July 19, 2024 -
Federal officials step down from health AI group’s board
HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.
By Emily Olsen • July 10, 2024