FDA urged to speed up review of mobile imaging tools to aid swamped radiologists

Industry advocates are asking the Food and Drug Administration to accelerate its review of imaging tools that could help busy radiologists better manage the COVID-19 pandemic.

The Medical Imaging and Technology Alliance recently implored the FDA, in particular, to temporarily prioritize the review and clearance of all movable radiologic platforms. Those include mobile x-ray, CT scanners and ultrasound systems, “which all play a role in the COVID-19 care pathway.” The latter, in particular, has been highlighted recently by Italian clinicians as a useful tool for coronavirus patient assessment and triage.

“Mobile imaging is a key component in responding where the crisis is most acute and imaging manufacturers are working with the FDA and other key agencies to increase the availability of medical imaging equipment where it is most needed,” Dennis Durmis, chair of MITA’s board of directors, said in a statement issued April 1.

In a March 26 letter to the FDA, MITA Executive Director Patrick Hope offered several more possible steps the agency might take to accelerate the flow of new imaging systems. Those could include leveraging third-party recommendations for imaging device submissions, granting manufacturers greater flexibility to use alternative device components.

They’re also asking the FDA to coordinate with the Department of Homeland Security and others to help meet demand for medical imaging devices in severely affected areas.

“We stand ready to work with the FDA to address this public health emergency by helping to ensure healthcare providers have the medical imaging resources they need to mitigate risk and save lives,” said Durmis, who is also senior vice president and radiology head for Bayer’s Americas Region.

In an announcement Tuesday, the FDA indicated that the administration is taking a “all-hand-on-deck” approach in responding to the pandemic. They’re looking to speed up approval of treatments for the novel virus,  working with more than 220 test developers to help expedite means of diagnosing COVID-19.  

“The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible,” Health and Human Services Secretary Alex Azar said in a statement. “As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.”

In guidance issued last month, the American College of Radiology urged providers to deploy portable radiography units in ambulatory care facilities for use when chest x-ray is considered medically necessary. Such devices are easily cleaned and would help to keep infected patients from entering radiography rooms, triggering stringent infection control procedures.