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

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

Why 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

Medtronic’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

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

AI 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

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The rescinded orders include directives boosting the Affordable Care Act exchanges, coordinating the government’s COVID-19 response and deploying artificial intelligence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

Top 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

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

FDA aims to stem AI device bias, boost transparency in draft guidance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

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

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

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

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

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

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

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

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

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

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

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

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