AI
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Courtesy of Beacon Biosignals
Deep Dive5 tips for building a predetermined change control plan
The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.
By Elise Reuter • March 25, 2025 -
Chip Somodevilla / Staff via Getty Images
Quest, Google team on gen AI; GE Healthcare plans autonomous imaging
GE Healthcare, Synchron and robotics companies were among the medtech firms that used Nvidia’s GTC 2025 conference to share updates on their work with the AI computing leader.
By Nick Paul Taylor • Updated March 20, 2025 -
Retrieved from Spectral AI on March 18, 2025
Spectral AI algorithms beat physicians in burn tissue assessments
The company plans to file the results with the FDA by mid-2025 and launch the product in 2026.
By Nick Paul Taylor • March 18, 2025 -
Andrew Harnik via Getty Images
Deep DiveHealthcare tackles AI oversight with no aid from Trump administration
The president’s deregulatory bent means more responsibility rests on the shoulders of healthcare stakeholders to get artificial intelligence right.
By Rebecca Pifer • March 14, 2025 -
Don Wu via Getty Images
ECRI warns insufficient AI governance threatens patient safety
ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.
By Nick Paul Taylor • March 11, 2025 -
Courtesy of Brainomix
Medtronic partners with Brainomix on AI stroke tool
Medtronic also recently teamed with Tempus to assess the use of artificial intelligence to identify people eligible for interventions like TAVR.
By Nick Paul Taylor • Feb. 28, 2025 -
Sarah Silbiger via Getty Images
Device industry scrambles as FDA job cuts cause delays
The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.
By Elise Reuter • Feb. 20, 2025 -
Elise Reuter/MedTech Dive
Advamed CEO warns FDA job cuts put patients, industry at risk
Scott Whitaker sent a letter to the HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S. leadership in medtech are on the line.
By Susan Kelly • Feb. 19, 2025 -
SeventyFour via Getty Images
Q&AWhy health systems should be ‘clear-eyed’ about business goals for AI tools
Caroline Pearson, the executive director of the Peterson Health Technology Institute, discusses the institute’s new task force studying the financial, efficiency and workforce effects of AI products.
By Emily Olsen • Feb. 10, 2025 -
Permission granted by Medtronic
Q&AMedtronic’s Orleigh Bogle on changing the culture of surgical training
Bogle, Medtronic’s head of medical affairs for digital surgery, also discussed the company’s plans to train surgeons for its Hugo surgical robot.
By Elise Reuter • Feb. 6, 2025 -
Elise Reuter/MedTech Dive
Troy Tazbaz, CDRH digital health leader, resigns
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.
By Elise Reuter • Jan. 31, 2025 -
Retrieved from Mass General Brigham on January 22, 2025
Deep Dive // 2025 outlookAI in medtech is taking off. Here are 4 trends to watch in 2025.
New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.
By Elise Reuter • Jan. 22, 2025 -
Christopher Furlong/Getty Images via Getty Images
Trump reverses Biden healthcare directives, withdraws from WHO in first executive orders
The rescinded orders include directives boosting the Affordable Care Act exchanges, coordinating the government’s COVID-19 response and deploying artificial intelligence tools.
By Emily Olsen • Jan. 21, 2025 -
eggeeggjiew via Getty Images
Deep DiveTop healthcare technology trends in 2025
How the incoming Trump administration will regulate AI this year remains unclear. Meanwhile, experts say healthcare companies will continue bolstering cyber defenses to withstand increasing attacks.
By Emily Olsen • Jan. 17, 2025 -
Martin Barraud via Getty Images
More hospitals need to assess predictive models for accuracy, bias: Health Affairs
Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for bias.
By Elise Reuter • Jan. 10, 2025 -
Elise Reuter/MedTech Dive
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.
By Elise Reuter • Jan. 7, 2025 -
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
