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“The ability to test saliva samples for the presence of SARS-CoV-2 … simplifies the sample collection process and streamlines the testing workflow, while reducing the exposure of medical personnel to potentially infected individuals,” the company said. Read More
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results,” said FDA Commissioner Stephen Hahn. Read More
The company noted the importance of acquiring Veran’s advanced electromagnetic navigation system that is used to visualize and access lesions in the lung’s peripheral regions. Read More
The clearance allows the device to be used for monitoring quarantined patients, enabling the distanced monitoring of contagious COVID-19 patients. Read More
“The applications of this [test] are ideal for companies working on vaccine development or COVID-19-related therapeutics,” said FlowMetric founder and CEO Renold Capocasale. Read More
The FDA has released new guidance aimed at easing inspection requirements for mammography equipment, acknowledging the challenges facing facilities during the COVID-19 pandemic. Read More
The FDA continues to issue warning letters for unapproved products to treat or detect COVID-19 and said it is taking “urgent measures” to protect consumers from products that, without the agency’s approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Read More
The FDA issued a warning letter to Batelle Memorial Institute in Columbus, Ohio, for its Critical Care Decontamination System, which received an Emergency Use Authorization on March 28. Read More
Combination product agreement meetings — known within the FDA as CPAMs — are a prime way sponsors of such products can gather agency feedback on their applications, the agency said in a final guidance released yesterday. Read More
The FDA issued final guidance for bioburden reduction systems that use dry heat to help support single-user reuse of certain particulate filtering facepiece respirators (FFRs) as the need for FFRs may outpace the supply available to healthcare organizations during the COVID-19 pandemic. Read More