Minutes September 16, 2025

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

NATIONAL ADVISORY COUNCIL FOR 

BIOMEDICAL IMAGING AND BIOENGINEERING

Summary of Meeting¹ 

September 16, 2025

The National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB) was convened for its 69th meeting on September 16, 2025, both in-person and online by Teams for the Open Session and Closed Session. Dr. Bruce Tromberg, Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) presided as Council chairperson. In accordance with Public Law 92-463, the meeting was open to the public from 9:05 a.m. to 12:30 p.m. and 1:40 p.m. to 2:53 p.m. and for review and discussion of program development, needs, and policy. The meeting was closed to the public from 2:53 p.m. to 2:56 p.m. for the consideration of grant applications.

Council members present:

Dr. Tamara Baynham, Ingenuity Medical Device Research, LLC, Antioch, TN

Dr. Tejal Desai, Brown University, Providence, RI

Dr. Wilbur Lam, Emory University School of Medicine, Atlanta, GA

Dr. Raphael Lee, The University of Chicago, Chicago, IL

Dr. Cynthia McCollough, Mayo Clinic, Rochester, MN

Dr. Tyrone Porter, University of Texas at Austin, Austin, TX

Dr. Christine Schmidt, University of Florida, Gainesville, FL

Dr. Daniel Sodickson, New York University Grossman School of Medicine, New York, NY

Dr. Joyce Wong, Boston University, Boston, MA

Ex officio member attending:

Dr. Vincent Ho, Uniformed Services University of the Health Sciences, Bethesda, MD

Dr. Nicholas Petrick, U.S. Food and Drug Administration, Silver Spring, MD

Ex officio members attending by Teams

Dr. Sohi Rastegar, National Science Foundation, Arlington, VA

Ex officio members absent:

Dr. Jay Bhattacharya, National Institutes of Health

Robert F. Kennedy, Jr., Department of Health and Human Services, Washington, DC

Chairperson:

Dr. Bruce Tromberg

Executive Secretary:

Dr. Anna Taylor

For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a conflict of interest may occur. This procedure only applies to applications that are discussed individually, not to “en bloc” actions.

NIBIB staff present for portions of the meeting:

Members of the public present for portions of the meeting:

Dr. Dawn Beraud

Dr. Patrick Bradshaw

Dr. William Grissom

Ms. Katie Grady

Dr. Jason Marvin

NIBIB staff attending portions of the meeting by Teams:

Dr. Erim Zeynep

Ms. Ashley Strom

Approximately 115 observers attended the open session, including NIBIB staff and members of the general public. 

Call to Order: Dr. Anna Taylor 

Dr. Anna Taylor called to order the 69th meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. She reminded attendees that the morning session of the meeting was open to the public and welcomed attendees.

Dr. Tromberg's report covered budget updates, policy changes, program highlights, and strategic initiatives. For FY25, NIBIB maintained a 12% R01 payline, 17% for new investigators, and 29% for early-stage investigators (ESI). This allowed the institute to maintain roughly the same number of R01 and ESI R01 awards as in previous years. Looking ahead to FY26, both the House and Senate markups proposed maintaining NIBIB's budget at the same level as FY25. Committee reports specifically called out NIBIB's RADX program and its collaborations with multiple institutes and centers. 

Dr. Anna Taylor presented an extensive overview of recent policy changes affecting the research community. Updates included: temporary extension of K99/R00 eligibility by up to three receipt dates; closeout requirements suspended for those with appeals pending on terminated awards; new compliance training requirements for other support disclosure beginning October 2025; and limits on grant applications to six per PI per calendar year. Additional policy updates covered new approaches to funding opportunities. Starting FY26, NIH will move publication of Notices of Funding Opportunities (NOFOs) from the NIH Guide to Grants.gov while maintaining NIH website tools for NOFO identification. NIH is reducing the number of NOFOs by approximately 50% and eliminating Notices of Special Interest (NOSIs) except for public health emergencies. NIH launched "highlighted topics" as a new communication tool to inform the community about scientific interests while encouraging investigator-initiated research through parent announcements. 

Taylor also addressed changes to international collaborations and animal research policies. NIH announced a new process for applications with foreign components requiring a multi-component PF5/UF5 structure with overall, research, and international components. All international collaboration applications will called to the attention of the Advisory Council. Regarding animal research, NIH will no longer develop funding opportunities focused exclusively on animal models but will incorporate other methodologies; individual applications can still include animal models if scientifically justified. Taylor noted increased focus on new approach methodologies (NAMs) where NIBIB's engineering community has significant expertise. 

Dr. Tromberg announced leadership changes at NIH, including the retirement of Dr. Noni Byrnes as Director of the Center for Scientific Review (CSR), the appointment of Dr. Bruce Reed as Acting Director of CSR, the permanent appointment of Dr. Jon Lorsch as the Deputy Director for Extramural Research, and the appointment of Dr. Erica Brown as Acting Director of the National Institute of General Medical Sciences. 

Dr. Tromberg highlighted several programmatic successes and initiatives. 

• The Design by Biomedical Undergraduate Teams (DEBUT) challenge saw remarkable growth, with 123 applications from 534 students at 67 universities in 24 states, and a total prize purse of $190,000 for 19 winning teams. Tromberg noted that while NIBIB's budget remains constrained, they have worked to recruit engagement from eight other NIH Institutes. 

• The Medical Imaging and Data Resource Center (MIDRC) submitted a pre-submission to FDA for Medical Device Development Tools (MDDTs), representing a significant milestone in establishing validated datasets for AI/ML testing 

• The PRIMED-AI Initiative (Precision Medicine with AI) announced five upcoming funding opportunities with first awards expected in fall 2026, with NIBIB leading the logistics and validation centers.

Tromberg concluded his report highlighting NIBIB activities at the NIBIB-American Institute for Medical and Biological Engineering (AIMBE) Congressional Tour held July 18, 2025 (with 47 congressional staff representing 30 states and territories in attendance), the upcoming Biomedical Engineering Society (BMES) meeting in October 2025, a joint NHLBI-NIBIB workshop on coronary artery disease imaging ,and the annual POCTRN meeting. Tromberg announced that intramural researcher Dr. Kaitlyn Sadtler received tenure as Senior Investigator in NIBIB in August 2025.

Dr. William Grissom, Medtronic Professor of Biomedical Discovery and Innovation at Case Western Reserve University, delivered the 11th annual Lopez lecture on focused ultrasound for neuromodulation. Dr. Grissom explained that unlike conventional diagnostic ultrasound, focused ultrasound uses high-powered transducers in transmit-only mode to manipulate tissue deep in the body with millimeter precision. He demonstrated the technique’s evolution from 1920s body applications to 1950s brain applications, noting that development stalled due to lack of intraoperative guidance and challenges delivering acoustic waves through the skull. 

The field was revitalized in the 1990s through two key developments: low-frequency phased arrays (operating at 220-650 kHz versus several MHz for diagnostic imaging) that could adapt to individual skull properties, and MRI guidance including MR thermometry for targeting and dosimetry. Dr. Grissom showed a compelling clinical video of essential tremor treatment at Stanford University, where a patient went from exhibiting severe hand tremors to immediate improvement after treatment, all while awake in the scanner with only local anesthesia. The procedure creates a tight lesion in the ventral intermediate nucleus of the thalamus with no skull opening required. 

Dr. Grissom’s research focuses on transcranial ultrasound stimulation for neuromodulation rather than ablation. Collaborating with colleagues at Vanderbilt University Medical Center, and with support from the NIH HEAL (Helping to End Addiction Long-term) Initiative, he co-developed an integrated platform combining focused ultrasound with functional MRI in non-human primates to study neuromodulation effects. Key technical innovations included MR acoustic radiation force imaging (MR-ARFI) to visualize and correct focus position through the skull, achieving sensitivity down to 50-100 nanometers of tissue displacement while operating well below regulatory limits on brain ultrasound exposure. His team has developed rapid 3D segmented sequences, spiral sequences, and magnitude-prepared MR-ARFI sequences that inherently fuse anatomical and functional information.

Looking forward, Dr. Grissom outlined major challenges requiring solutions: replacing expensive MRI guidance with more accessible alternatives like low-field MRI or ultrasound-only methods including fullwave inversion; improving head fixation techniques; implementing online full-wave simulations for better aberration correction; achieving CT-free skull property measurements; and solving acoustic coupling for consumer devices. Despite these challenges, he expressed optimism that wearable neuromodulation devices are achievable, primarily limited by acoustic coupling and power electronics miniaturization rather than fundamental physics constraints.

BRITE Program (Bioengineering Research, Innovation and Technology Education Program) – Tina Gatline, PhD., Program Director, Division of Interdisciplinary Training

Dr. Tina Gatlin presented the Bioengineering Research, Innovation and Technology Education (BRITE) program concept, an R25 research education program for early-stage undergraduate students. The program would support freshman and sophomore students through a summer bridge program (5+ weeks), academic year activities including part-time research and innovation/entrepreneurship training, and full-time summer research experiences after freshman and sophomore years. Students could continue engagement in junior and senior years through honors programs and near-peer mentoring. 

The concept aims to address workforce development priorities articulated in the NIH Director's Unified Funding Strategy, with evidence showing that structured undergraduate research programs with financial support, mentoring, and authentic experiences lead to improved degree completion rates and research career commitment. BRITE would fill a gap at the early undergraduate level, complementing NIBIB's existing Team-Based Design (TBD) program for late-stage undergraduates. Proposed structure includes up to $335K direct costs with 8% indirect costs, with project periods up to five years and limiting one application per institution. Institutional eligibility requires baccalaureate degree granting, engineering college/school with at least a bioengineering concentration, and NIH funding averaging less than $50 million/year over three years. Council discussion focused on partnership opportunities, regional workforce development connections, and flexibility around the funding threshold to encourage collaborations between lower-resourced and well-resourced institutions.

NIBIB Technology Development Networks – Presenter: Luisa Russell, Ph.D., Program Director, Division of Discovery Science and Technology

Dr. Luisa Russell presented a concept for Technology Development Networks centered around coordinating centers (likely U24 cooperative agreements) designed to enable novel technologies to progress through discovery, development, and commercialization. The networks would feature opportunity funds and community-based approaches to convene researchers, identify shared translational challenges, catalyze solutions through working groups, and accelerate translation from bench to bedside by connecting people, solving problems, and providing shared resources. 

The concept proposes a standardized structure with central administration supported by cores for education/training, translation expertise, computation/AI, and notably an ethics core. The ethics component addresses community engagement, end-user perspective, responsible development, legal implications, and clinical trial readiness—focusing on adoption considerations beyond just FDA approval. Dr. Russell highlighted three potential application areas: engineered biology (shaping an emerging field and accelerating design efficiency), microsystems (focusing on interfaces between electronics and living/non-living components), and robotics (closest to clinic, optimizing materials, parts, and connecting research sites). The networks could enable rapid solicitations through opportunity funds, develop consensus standards, address ethical issues, and create communities of researchers ready to solve biomedical problems. Council discussion emphasized partnership opportunities with industry, other federal programs like NSF I-Corps, and standards organizations, while noting the networks would be scientifically rather than geographically focused.

RADx SBIR – Presenter: Todd Merchak, Director, Office of Program Evaluation and Strategic Partnerships (OPESP)

Mr. Todd Merchak presented a concept combining the established Small Business Innovation Research (SBIR) program with the Rapid Acceleration of Diagnostics (RADx) innovation funnel approach. The NIH SBIR program represents one of the largest sources of early-stage capital for life sciences at over $1.4 billion 6 annually across NIH, providing non-dilutive seed funding. The RADx program's innovation funnel successfully accelerated projects through R&D, clinical and regulatory studies, and manufacturing scale-up, gaining expertise on systematic derisking of both technology and business models. 

The concept would implement a RADx approach for SBIR projects as a pilot program starting with a small number of awards. Primary objectives include reducing time from submission to award, utilizing stage-gated milestones to expedite path to market, and leveraging expertise from partner Institutes and Centers for collaborative funding opportunities. In FY25, NIBIB brought in roughly $30 million in co-funding for RADx collaborative initiatives, demonstrating the potential for continued partnership success. The initiative would feature flexible solicitation allowing quick response to opportunities, mechanism flexibility (grants, cooperative agreements, contracts), annual topic area releases, and strong programmatic oversight to balance mission coverage with emerging opportunities. NIBIB will continue supporting SBIR/STTR grants through omnibus solicitations. Council discussion focused on mechanisms for timeline reduction and whether the focus would be on advanced-stage technologies or if timelines would extend to earlier development phases.

The open session of the NACBIB meeting was adjourned at 12:30 p.m. and 2:53 p.m.

Review of Council Procedures and Regulations: Dr. Anna Taylor 

The grant application review portion of the meeting was closed to the public in accordance with provisions set forth in Section 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). 

Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications which there was a potential conflict of interest, real or apparent.

The National Advisory Council for Biomedical Imaging and Bioengineering considered 1405 research and training applications requesting $2,742,896,32 in total costs. The Council recommended 1405 applications with a total cost of $2,742,896,32.

Adjournment

The closed session was adjourned at 2:56p.m.