Advanced Imaging Group Calls For Swifter FDA Approvals For Mobile X-Ray, CT, Ultrasound Devices For COVID-19 Crisis
The Medical Imaging & Technology Alliance recently sent a letter to the US FDA recommending steps the agency can take to help the advanced imaging industry quickly respond to the COVID-19 outbreak.
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The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health.
The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.
Butterfly Network is disseminating the lessons from China and Italy about the poential value of lung ultrasound in the management of COVID-19 patients with respiratory disease.