It is now becoming more widely recognized that focused ultrasound has the potential to both improve the lives of millions of people with a wide variety of serious medical disorders and to propel the creation of a new multibillion-dollar industry.

Highly disruptive therapeutic technologies like focused ultrasound evolve exponentially from laboratory research to widespread utilization as a standard of care. In the case of focused ultrasound, the inflection point in the clinical adoption curve has recently been reached, and the dialogue has shifted from "if" the technology will have an important role in the therapeutic armamentarium to "when."

While strong progress has been made in achieving this vision in the last several years, it is also becoming increasingly apparent that the pace of progress needs to be accelerated. Every month that transpires where the technology is not available translates into unnecessary death, disability, and suffering for countless people. Saving time equals saving lives.

In 2018, the United States Food and Drug Administration (FDA) established the Breakthrough Devices Program (BDP), which allows for fast-tracking the approval of certain novel devices or device-led combination products (products that are therapeutic and/or diagnostic that combine drugs, devices, or biological products.) The goal of this program is to expedite patient access to devices that provide more effective treatment or diagnosis, through a more rapid assessment and review process, while preserving the FDA’s standards of approval. This program replaces the Expedited Access Pathway (EAP) and Priority Review for medical devices programs, as the EAP did not include 510(k) applications and the priority review is now limited only to drugs, and not devices.

The BDP offers device manufacturers an opportunity to work directly with the FDA through the review stage of the pre-market approval (PMA) process. Devices that are subject to PMA, 510(k), or requests for de novo designation are eligible for Breakthrough Device designation if they meet two criteria:

On January 14, 2021, the Foundation hosted a panel discussion in conjunction with a virtual screening of Picture a Scientist. The discussion, moderated by Jessica Foley, PhD (Chief Scientific Officer, Focused Ultrasound Foundation), brought together women leaders in focused ultrasound – Katherine W. Ferrara, PhD (Professor of Radiology, Stanford University); Elisa Konofagou, PhD (Professor of Biomedical Engineering, Professor of Radiology, Director of the Ultrasound and Elasticity Imaging Laboratory, Columbia University); Wanda Nicholson, MD, MPH, MBA (Professor in General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine); and Natasha Sheybani, PhD (Postdoctoral Research Fellow, Stanford University and Senior Scientist, Focused Ultrasound Foundation) – to reflect on the film, their own experiences, and how we can work together to bring more equity, diversity and inclusion to our field.

This blog post – which coincides with the 2021 International Day of Women and Girls in Science – summarizes some of the statistics regarding the representation of women and minorities in science and engineering. The blog features highlights from the panel discussion and introduces a new Focused Ultrasound Foundation initiative to support and advance the role of women in our field.

(Join the Women in Focused Ultrasound Interest Group >)

At the risk of stating the obvious, in too many ways 2020 was the worst year in memory. But anomalously, despite many challenges, it was a good year for focused ultrasound.

I am pleased to report that with your support, the Foundation was able to thrive during the pandemic, and major progress was made in the field.

Frustratingly, focused ultrasound technology has had nothing to offer in the management of COVID. Appreciating this, we kept our heads down this past year and continued working diligently on accomplishing our mission of accelerating the development and adoption of focused ultrasound as a standard of care globally – because in the long term, the importance of this revolutionary, game-changing technology was, and is, undiminished.

The following blog is adapted from a video made by Focused Ultrasound Foundation Council member Harry Lester. Find out what Harry has to say about his diagnosis with Stage IV lung cancer, his experience with immunotherapy, and his hope for focused ultrasound to increase the effectiveness of lung cancer treatments.

Recently, I celebrated my 75th birthday, and I'm the luckiest guy I know. Let me tell you why.

Almost five years ago, I had a cough that wouldn't go away. I have a great doctor, and he kept trying to figure it out. Finally, he sent me to a pulmonary specialist. After some tests, he determined that I had stage IV lung cancer.

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