News | Coronavirus (COVID-19) | April 24, 2020

Increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of healthcare facilities, which could help to reduce the spread of COVID-19

#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2

Getty Images


April 24, 2020 — The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability and capability of medical X-ray, ultrasound and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) exposure to COVID-19 for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on Jan. 31, 2020, effective Jan. 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services Act (42 U.S.C. 247d(a)(2)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

For more information: www.fda.gov

Related Coronavirus Content:

VIDEO: Imaging COVID-19 With Point-of-Care Ultrasound (POCUS)

The Cardiac Implications of Novel Coronavirus

CT Provides Best Diagnosis for Novel Coronavirus (COVID-19)

Radiology Lessons for Coronavirus From the SARS and MERS Epidemics

Deployment of Health IT in China’s Fight Against the COVID-19 Epidemic

Emerging Technologies Proving Value in Chinese Coronavirus Fight

Radiologists Describe Coronavirus CT Imaging Features

Coronavirus Update from the FDA

CT Imaging of the 2019 Novel Coronavirus (2019-nCoV) Pneumonia

CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV)

Chest CT Findings of Patients Infected With Novel Coronavirus 2019-nCoV Pneumonia 

Find more related clinical content Coronavirus (COVID-19)

ACC COVID-19 recommendations for the cardiovascular care team

VIDEO: What Cardiologists Need to Know about COVID-19 — Interview with Thomas Maddox, M.D.

The Cardiac Implications of Novel Coronavirus

ESC Council on Hypertension Says ACE-I and ARBs Do Not Increase COVID-19 Mortality


Related Content

News | Radiology Business

April 23, 2024 — A diverse writing group—lead by authors at the University of Toronto—have developed an approach for ...

Time April 23, 2024
arrow
News | FDA

April 23, 2024 — Royal Philips , a global leader in health technology, today announced its Philips Zenition 30 mobile C ...

Time April 23, 2024
arrow
News | Ultrasound Imaging

April 22, 2024 — GE HealthCare announced the launch of the Voluson Signature 20 and 18 ultrasound systems, which ...

Time April 22, 2024
arrow
News | Artificial Intelligence

April 19, 2024 — Large language model GPT-4 matched the performance of radiologists in detecting errors in radiology ...

Time April 22, 2024
arrow
News | Lung Imaging

April 17, 2024 — A Medicare policy requiring primary care providers (PCPs) to share in the decision-making with patients ...

Time April 17, 2024
arrow
News | Radiology Business

April 17, 2024 — VISTA.AI announced the appointment of Daniel Hawkins as President and CEO. The company is pioneering AI ...

Time April 17, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 17, 2024 — Hyperfine, Inc., a groundbreaking health technology company that has redefined brain imaging with the ...

Time April 17, 2024
arrow
News | Mammography

April 16, 2024 — The Radiological Society of North America (RSNA) and GE HealthCare announced their collaboration to ...

Time April 16, 2024
arrow
News | ACR

April 15, 2023 — The American College of Radiology (ACR) released an update to its ACR Appropriateness Criteria (ACR AC) ...

Time April 13, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 10, 2024 — Online MRI and CT education leader, ImagingU, announced the launch of a new course for students and ...

Time April 10, 2024
arrow
Subscribe Now