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Educational Sessions

Basic Science and Instrumentation

From concept to FDA approval: Entrepreneurs' stories of clinical device innovations

Tuesday, April 1, 2025
1:00pm – 2:30pm .
Location:FL Salon I
CE: 0.0

Ultrasound and functional imaging? Ultrasound for bone imaging? Hands-free ultrasound for hemodynamic monitoring? Yes, yes and yes! Three startups—Seno Medical, Rivanna Medical, and Flosonics Medical—have recently introduced FDA-approved devices with such ground-breaking capabilities. Seno's Imagio system embodies a clinical optoacoustic modality aimed at addressing the persistent challenges in breast cancer diagnosis. Rivanna's Accuro is a hand-held device that has re-invented the ultrasound transducer and image formation algorithms for bone imaging, enabling precise spinal anesthesia guidance. Flosonics' Flopatch represents a first-of-its-kind wireless Doppler ultrasound patch for real-time fluid resuscitation management in acute care settings including shock and sepsis. In this session, the top engineering leaders of these startups will discuss their experiences, including both successes and setbacks, in advancing Basic Sciences and Instruments from concept to FDA approval. They will share major clinical study highlights as well as lessons learned.

    Speaker(s)

  • Bryan Clingman

    CTO & VP of Engineering
    Seno Medical
    San Antonio, United States

    Disclosure(s): No relevant disclosure to display

  • Mai Elfarnawany, PhD, PMP, PEng

    VP of Engineering
    Flosonics Medical
    Toronto, Canada

    I do not have any relevant financial / non-financial relationships with any proprietary interests.

  • Adam Dixon, PhD (he/him/his)

    Executive VP of Engineering
    Rivanna Medical
    Charlottesville, United States

    Disclosure(s): No relevant disclosure to display

Learning Objectives:

  • Gain a more holistic appreciation of how the entire ultrasound ecosystem must come together to enable clinical innovations: from technical inventions, to engineering development, clinical studies and regulatory approvals.
  • Outline a basic understanding of a recently FDA-cleared optoacoustics imaging modality that is elevating clinical ultrasound from an anatomical to a functional imaging modality with breast Dx as the first clinical application
  • Describe two other recently FDA-cleared novel PoC ultrasound devices including their underlying technologies, unique capabilities, current clinical applications and latest clinical evidence.

Disclosure(s):
Larry Mo, PhD: No financial relationships to disclose
Bryan A. Clingman: No relevant disclosure to display
Adam J. Dixon, PhD: No relevant disclosure to display

Presentations:

  • 1:00pm – 1:30pm .
    Meet a New Imaging Modality: Optoacoustics & Ultrasound for Breast Diagnosis

    Bryan A. Clingman – Seno Medical

  • 1:30pm – 2:00pm .
    Bone enhanced ultrasound imaging: enabling new applications in anesthesia guidance.

    Adam J. Dixon, PhD (he/him/his) – Rivanna Medical

  • 2:00pm – 2:30pm .
    Engineering Flopatch: From Scientific Vision to Clinical Impact

    Mai Elfarnawany, PhD, PMP, PEng – Flosonics Medical