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iHealth Unveils At-Home Antigen Test for COVID-19 and Flu A&B

Posted by Andy Lundin | May 8, 2024 | Covid 19 |

iHealth Labs received FDA Emergency Use Authorization for its COVID-19/Flu A&B Rapid Test Kit, enabling quick self-testing at home.

Luxor Scientific partnered with Orchard Software to expand its lab testing services with improved scalability and connectivity.

ADLM’s new guidance on clinical testing for respiratory viral infections emphasizes the use of advanced diagnostic methods and sample types.

The personal journey of co-author and physician Dana Mitchell details the challenges of accurate diagnosis of autoimmune encephalitis.

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.