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Software for Rapid Sepsis Diagnosis Gets FDA De Novo Marketing Authorization

The Sepsis ImmunoScore is an AI/machine learning software as a medical device to guide rapid diagnosis and prediction of sepsis.

Posted by Chris Wolski | Mar 6, 2024 | Lab Management |

These six best practices, which include automated software options and third-party assistance, can lead to better reimbursement.

Posted by Andy Lundin | Mar 5, 2024 | Compliance |

Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA’s proposed rule to regulate LDTs believe it will hurt their labs.

A new study aimed to develop a non-invasive method for early detection of GDM using cell-free DNA (cfDNA) and deep learning models.

Babson Diagnostics’ highly-automated microsample laboratory has been awarded accreditation by the College of American Pathologists (CAP).