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
From - Diagnostic Testing & Emerging Technologies
On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform…
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the…
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also…