Accelerating Cardiovascular Device Innovation Through Regulatory Science Workshop

November 12–13, 2026

The National Heart, Lung, and Blood Institute, in collaboration with the Food and Drug Administration’s Center for Devices and Radiological Health, will convene a virtual workshop on regulatory science approaches to accelerating cardiovascular device innovation. The workshop will explore key opportunities, evidence needs, technology challenges, and regulatory considerations relevant to academic, industry, and regulatory affairs communities.

Consensus standards, regulatory science tools, and validated methods can improve predictability, clarify regulatory expectations, facilitate premarket review, and support market access. However, developing and adopting these resources can be time-consuming, particularly for emerging technologies and novel device areas, placing the burden on early developers and innovators.

Regulatory science tools and approaches can help reduce reliance on ad hoc testing methods and support more efficient data generation and assessment. Accordingly, the workshop will examine how shared methodologies, validation practices, and regulatory review approaches can reduce uncertainty and improve cardiovascular device development and evaluation.

The overarching goals of the workshop are to:

· Highlight regulatory science resources and approaches for cardiovascular device development and evaluation.

· Foster cross-sector discussion to strengthen evidence, improve predictability, and support safe, effective cardiovascular technologies.

· Identify key gaps and challenges affecting regulatory readiness and innovation.

The workshop will address regulatory science approaches across several key areas:

· Artificial intelligence, machine learning, software as a medical device (SaMD), and software-enabled regulatory evaluation

· In silico modeling, in vitro testing, and new approach methodologies (NAMs) for cardiovascular devices

· Cardiovascular diagnostics, wearables, and connected monitoring

· Innovative cardiovascular treatment devices

· Evidence generation, real-world data, and lifecycle evaluation

· Early clinical translation and trial innovation

Each session will highlight available resources, ongoing development efforts, evidence and validation needs, regulatory review considerations, and key gaps and opportunities.

Event Details:

📅 Date: November 12–13, 2026
💻 Virtual Workshop: A link to join the virtual workshop will be sent closer to the workshop. Registration for this workshop is free and required to attend.

Contact:

For questions or to request reasonable accommodations to participate in this event, please email Rashaad Houston at rashaad.houston@nih.gov.