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
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
Liron Pantanowitz, MD, PhD, discusses the key issues pathologists face today, and how technology could help.
Artificial intelligence won’t take your job—but what are the real concerns around healthcare AI and its use?
AI is an increasingly useful tool in pathology—but its full value can only be realized in collaboration with human experts.
Diana W. Bianchi, MD, discusses how NIPT has evolved, key challenges, as well as her team’s research on using these tests to detect cancer.
Genomic sequencing is almost twice as likely to yield a diagnostic result, but lags behind panel testing in speed, cost, and concordance.
Using LIMS and no-code solutions can unlock opportunities for efficiency.
Tackling the challenges of “forever chemicals” in the diagnostics industry.
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
New ACMG recommendations aim to make CFTR carrier detection more equitable among a wider range of ancestries.