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AMP Celebrates Decision to Vacate FDA Rule on LDT Regs

Posted by Chris Wolski | Jun 3, 2025 | Compliance |

A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.

Posted by Chris Wolski | May 30, 2025 | Cytology |

AIxMed and Lumea have partnered to integrate AIxMed’s urine cytology diagnostic tool, AIxURO, into Lumea’s digital pathology platform.

Posted by Chris Wolski | May 23, 2025 | Compliance |

A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.

A strategic partnership has formed to accelerate the development a test for early ovarian cancer diagnosis using AI-powered analytics.

Posted by Chris Wolski | May 15, 2025 | Compliance |

The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.