FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.