Blog

An Inside Look at Obtaining Breakthrough Device Designation

Written by Sean Taffler, PhD
Published:
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:
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Sean Taffler

Writing a New Chapter – Women in Focused Ultrasound

Written by Natasha Sheybani, PhD, and Jessica Foley, PhD
Published:
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 >)
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Sheybani and Foley

Reflections on 2020 and Looking Ahead to 2021

Written by Neal F. Kassell, MD
Published:
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.
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A Patient Perspective: Cancer Immunotherapy and the Promise of Focused Ultrasound

Written by Harry Lester
Published:
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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Harry Lester

Adaptation and Resilience – Focused Ultrasound Field Responds to Impact of COVID-19

Written by Jessica Foley, PhD
Published:
[Updated 1/28/21; originally published 10/30/20] As we begin this new year, we are awed by the resilience of the entire focused ultrasound community despite the unpredictable nature of the past 12 months. The COVID-19 pandemic has had a dramatic impact on all our lives – our homes, our families, our businesses, and our health have all been affected. The focused ultrasound community is no exception. As the SARS-CoV-2 virus began to spread globally in early 2020, focused ultrasound laboratories around the world shut down, clinical trials were halted, and employees of the many focused ultrasound companies moved to remote work. Because most focused ultrasound procedures were deemed “elective,” for many months most patients were unable to access focused ultrasound treatments for essential tremor, pain or even cancer.
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