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FDA Issues Warning Against Using Cue Health COVID Tests

Posted by Andy Lundin | May 14, 2024 | Covid 19 |

The FDA warned against using Cue Health’s COVID tests due to modifications that reduced test reliability and increased risk of false results.

The LDT final rule has sent shock waves through the clinical diagnostics industry. Should you be worried, and what can you do about it?

Posted by Andy Lundin | May 9, 2024 | Digital Pathology |

Indica Labs received FDA clearance for HALO AP Dx, an enterprise digital pathology platform for primary diagnosis.

Posted by Andy Lundin | Apr 29, 2024 | Compliance |

The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.

Bruker enhanced diagnostic solutions in microbial identification, antimicrobial susceptibility testing, early sepsis diagnostics, and more.