As the Coronavirus Disease 2019 (COVID-19) continues to challenge the United States’ healthcare system, the Food and Drug Administration (FDA) is attempting to aid response efforts by adjusting regulations. Relaxed imaging regulations, while temporary, could be a major step towards the democratization of ultrasound.
As the Coronavirus Disease 2019 (COVID-19) continues to challenge the United States’ healthcare system, the Food and Drug Administration (FDA) is attempting to aid response efforts by adjusting regulations. Namely, the FDA eased medical imaging regulations in its Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, to make equipment more available for healthcare providers to use for COVID-19 cases during the health crisis. Relaxed imaging regulations, while temporary, could be a major step towards the democratization of ultrasound.
Deregulation of medical imaging
From the beginning of the pandemic, ultrasound systems—mostly in point-of-care (POC) and primary care applications—have been utilized to triage, monitor, and diagnose COVID-19 patients. The FDA sought to expand the use of ultrasound imaging for COVID-19, so it included new guidelines in that allow ultrasound scans to be performed “outside of its cleared environment of use… by healthcare practitioners who are not trained in sonography, under the guidance or supervision of a trained or licensed healthcare practitioner”, and for additional “lung scanning clinical applications” (Source: FDA). The adapted guidelines also allow healthcare providers to alter software to aid in the identification, measurement, and analysis of COVID-19 related symptoms. The FDA’s modifications for ultrasound will likely see immediate and substantial results due to the modality’s portability, affordability, and ease-of-use. Access to ultrasound will rapidly expand as more medical professionals will be allowed to perform examinations and in unconventional settings. The already elevated demand for POC and primary care ultrasound will be even higher since healthcare providers are seeking immediate solutions to diagnose the influx of sick patients. From an installation and training standpoint, new ultrasound systems are faster and cheaper to introduce to a healthcare center compared to other medical imaging equipment used for diagnosis of complications from COVID-19, such as X-ray and CT. Ultrasound does not require radiation, making it a safer option.
Development of technology
Clearly, full FDA clearance of ultrasound use by the general public is not expected for a very long time, if at all. Nonetheless, technological advancements, such as artificial intelligence (AI) and telemedicine have made significant leaps, making the idea of public use of ultrasound more plausible. AI for ultrasound has primarily been development for clinical applications unrelated to COVID-19. For example:
- Caption Health’s Caption Guidance software guides practitioners through cardiac ultrasound exams.
- DiA Imaging Analysis’ LVivo Toolbox offers a set of AI tools that assist in real-time diagnostics for cardiac exams.
- Koios Medical’s DS Breast 2.0 algorithm is trained to detect breast cancer from breast ultrasounds.
Similar AI technology can be applied to lung ultrasounds, to aid practitioners for use on COVID-19 patients.
Many ultrasound manufacturers have developed telemedicine tools that connect the ultrasound users to radiologists and sonographers. AI and telemedicine aid in the operation and interpretation of ultrasound examinations, minimizing the necessity for a highly trained sonographer, which is important during the current health crisis and for the future expansion of the use of ultrasound.
Before the onset of the pandemic, Butterfly Network emerged as a key player in the POC and primary care space by applying AI and telemedicine to handheld ultrasound. In 2017, Butterfly Network launched the Butterfly iQ, an AI-enabled full body scanner utilizing a silicon chip, which allows for a single probe to be used for many clinical applications. The Butterfly iQ costs under $2,000 and healthcare providers pay a subscription to use the device and its platform. The low equipment cost and versatility of the Butterfly iQ make it very accessible, which aligns with Butterfly Network’s mission to “democratize healthcare” (Source: Butterfly Network). The subscription model seems to appeal to the public in an era of subscription television and music services. Despite Butterfly Network’s recent success, major barriers have stood between them and their goal, including FDA regulations. The easing of regulations will allow more practitioners to use devices like the Butterfly iQ during the pandemic.
Democratization of ultrasound
While the FDA’s regulation modifications are only intended for the duration of the public health crisis, the impact could be long-lasting. The temporary allowance of ultrasound scans performed by untrained medical staff will test the necessity of training for the use of ultrasound, which many believe could one day be in the hands of the public. If untrained practitioners can safely and successfully perform ultrasound scans during the pandemic, it would be a positive indicator that the technology is advanced enough for the FDA to consider permanently relaxing regulations. The permanent easing of guidelines could be the first domino to fall on the road to democratization of ultrasound.
History of medical advancements
Ultrasound would not be the first highly regulated medical advancement to become mainstream, especially in the presence of a crisis. During World War II, a variety of infections presented a major health emergency for military forces. To address this issue, the United States government took over and expedited the mass production of the antibiotic, penicillin, for the war effort. Following the war, penicillin was made available to the general public in many countries, including the United States (Source: Centers for Disease Control and Prevention (CDC)). Similarly, the development of the now commonplace EpiPen® was the result of a crisis. During the Cold War between the United States and Soviet Union, the United States government instigated the development of an auto-injector for nerve agents to combat chemical warfare. Following the war, the inventors of the auto-injectors saw the device’s potential to be used for allergic reactions by injecting epinephrine, so the devices were repurposed and improved. The EpiPen® gained FDA approval in 1987 and is now ordinary for personal use (Source: Business Insider).
Impact of COVID-19
Once the COVID-19 public health crisis subsides, the FDA will likely revert to its previous guidelines for medical imaging. Nonetheless, the current situation will serve as a test run for the outlook of deregulated ultrasound use, which could be a path toward democratized ultrasound. Omdia will continue to closely monitor the virus and its impact on the ultrasound market and provide frequent insight and up-to-date forecasts as part of the newly introduced quarterly updates to the Ultrasound Intelligence Service.