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

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

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

FDA seeks feedback on generative AI regulations

The agency published a discussion paper this week as it considers the “unique risks” and potential promise of generative AI for patient care.

By Elise Reuter • Aug. 19, 2026

FDA names second participant in TEMPO digital health pilot

Cadence, a company that makes AI-enabled software to support hypertension management, will join the pilot, which allows companies to collect real-world data through Medicare.

By Elise Reuter • Aug. 17, 2026

From the clinic to the community: advancing healthcare innovation

See how Dell and NVIDIA are bringing AI-powered solutions to every point of care.

By Sandra Colner • Aug. 17, 2026

CHAI creates work group to counter frontier AI model cybersecurity risks

CHAI plans to create playbooks to help organizations defend against — and leverage — these powerful systems.

By Jill Hughes • Aug. 14, 2026

Medtronic on the future of AI-assisted surgery

Medtronic’s George Murgatroyd says an advanced computing platform that works with the company’s Hugo robot will power AI algorithms that can assist surgeons as they operate.

By Susan Kelly • Aug. 5, 2026

Caristo wins FDA authorization for cardiovascular risk predictor

The University of Oxford spinout will soon launch the AI tool, which research suggests could help assess heart attack risk in patients who don’t have obstructive coronary artery disease.

By Nick Paul Taylor • Aug. 4, 2026

DeepHealth gets FDA nod for AI tool that reads ultrasounds, creates reports

DeepHealth’s tool automates lesion detection, characterization and reporting from breast ultrasound scans.

By Elise Reuter • Aug. 4, 2026

The FDA was all in on AI. Will that change?

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

By Kelly Bilodeau • July 29, 2026