How should the FDA regulate generative AI in medtech? Here are 5 takes

Patients, providers and medtech firms submitted hundreds of comments to the Food and Drug Administration on how the agency should approach generative AI in medical devices.

By Elise Reuter • Nov. 3, 2026

AI vendors, health systems join physicians in liability for clinical AI: AMA

The AMA's new issue brief assigns distinct responsibilities to physicians, developers and healthcare organizations, arguing that protecting patients requires accountability from all stakeholders.

By Anuja Vaidya • Nov. 3, 2026

Explore the Trendline➔

AI tools are transforming the medtech space

As artificial intelligence becomes more prominent in the medtech sector, the technology is changing what it means to be a medical device — and attracting top companies.

By MedTech Dive staff

Medical device leaders share AI hot takes at The MedTech Conference

Medtech CEOs and consultants advised focusing on a core market and preparing for complex processes in a highly regulated industry.

By Elise Reuter • Oct. 27, 2026

Developers, not doctors, should be held accountable for generative AI medical devices, providers say

Provider groups are lobbying the Food and Drug Administration to make tech companies responsible for the safety and performance of generative AI-backed medical devices, arguing the tools’ makers are best equipped to evaluate them.

By Anuja Vaidya • Oct. 23, 2026

Gen AI policy is a White House priority, CDRH digital health leader says

Rick Abramson, director of the FDA’s Digital Health Center of Excellence, said to expect draft guidance in the coming months.

By Elise Reuter • Oct. 21, 2026

AI that understands, reasons and acts: Closing the integration gap in enterprise imaging

Agentic AI assists with routing urgent scans, cutting minutes to treatment.

By Veronica Thums • Oct. 19, 2026

AMA releases governance framework for agentic AI in healthcare

Industry groups have worked to release guidance on artificial intelligence-backed agents in the absence of federal regulation.

By Anuja Vaidya • Oct. 16, 2026

Agilent to buy Proscia for $240M

The digital pathology firm “fits in very well” with Agilent and moves the company into a sector targeted by Roche, analysts said.

By Nick Paul Taylor • Oct. 14, 2026

UK backs continuous oversight of AI medical devices

The Medicines and Healthcare Products Regulatory Agency adopted 44 recommendations, including a call for AI-enabled devices to be monitored throughout their working life.

By Elise Reuter • Oct. 7, 2026

ARPA-H awards more than $100M to biosensor development projects

Four organizations will develop devices for tracking heart disease, inflammation and perimenopause.

By Nick Paul Taylor • Oct. 5, 2026

FDA to prioritize guidance on AI, surgical robots next year

The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.

By Nick Paul Taylor • Oct. 2, 2026

Data privacy concerns could hold patients back from using AI

Although artificial intelligence has quickly become integrated into our daily lives, Americans say they’re becoming increasingly concerned about their health data.

By Anuja Vaidya • Oct. 1, 2026

GE HealthCare hires new global chief AI officer

Rodolphe Katra has joined from Medtronic to lead GE HealthCare’s efforts to connect devices, software and data.

By Nick Paul Taylor • Sept. 30, 2026

GE HealthCare to explore applying generative AI to radiation therapy workflows

The company has teamed up with a Mass General Brigham research team to help care teams access patient-specific information.

By Nick Paul Taylor • Sept. 28, 2026

AI will inflate healthcare costs before lowering them, Oz says

AI will “turbocharge” medical billing and drive up costs in the short term, CMS Administrator Dr. Mehmet Oz warned Wednesday. But he says the pain is worth it for long-term savings.

By Jill Hughes • Sept. 24, 2026

BD hires Arthur Hu as chief information and digital officer

BD predicted that Hu’s experience at Lenovo will be an important advantage as technology becomes increasingly central to how leading medtech companies operate.

By Nick Paul Taylor • Sept. 24, 2026

Agentic AI in MedTech: Driving efficiency and care outcomes

Agentic AI moves healthcare beyond reactive tools to orchestrate entire clinical workflows—improving efficiency and patient outcomes.

By Susmit Pal • Sept. 21, 2026

Mayo Clinic, Thermo Fisher partner to create Precure

The company will generate population-scale molecular data to inform development of diagnostics, therapies and other healthcare products.

By Nick Paul Taylor • Sept. 21, 2026

Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI

Cognita’s method will test a way of evaluating AI-generated radiology reports as the FDA considers how to regulate generative AI-enabled devices.

By Elise Reuter • Sept. 18, 2026

Healthcare’s agentic AI boom is outpacing governance: report

Patient safety could be at risk if agentic AI tools are rolled out without proper guardrails, Imprivata’s chief medical and growth officer warns.

By Jill Hughes • Sept. 18, 2026

ARPA-H to award $62.7M for AI in cardiovascular care

Companies including Tempus AI and Updoc are tasked with building an agentic AI system for managing heart failure.

By Elise Reuter • Sept. 11, 2026

4 questions about the FDA’s approach to generative AI

The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent.

By Elise Reuter • Sept. 9, 2026

Elucid raises $55M to commercialize cardiovascular imaging platform

Elucid, which gained a large medtech company as an investor, plans to grow industry partnerships as it looks to expand its AI-powered imaging platform.

By Nick Paul Taylor • Sept. 8, 2026

Vara receives CE mark for first autonomous breast cancer screening

The AI-enabled device can report screenings it determines are normal without radiologist review.

By Elise Reuter • Sept. 4, 2026

Vitestro secures FDA nod for robotic blood draw device

The Food and Drug Administration hailed the potential of the first-of-its-kind device to counter the U.S. phlebotomist shortage. 

By Nick Paul Taylor • Aug. 20, 2026