New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Experts offer advice in a recent commentary article on treating patients who may have monkeypox during the current COVID-19 pandemic.
Georgia health system hospitals are the first to be penalized for failing to update their websites or reply to agency warning letters.
The creation of Global Access Diagnostics aims to expand affordable access to quality tests around the world.
The number of non-COVID-19 tests billed to Medicare during the pandemic has decreased compared to the six-month period before COVID-19.
For the first time, the FDA has granted emergency use authorization for a test to differentiate strains of the SARS-CoV-2 virus.
Three labs, their owner, two lab marketing companies, a fourth lab, and a physician are accused of kickbacks, money laundering, and fraud.
A new AI method developed by the National Cancer Institute could produce results similar to regular CT scans, but without exposing patients to radiation.
Effective June 1, the agency is once more accepting pre-submission requests for all in vitro diagnostics, including non-COVID-19 tests.
With threats and attacks increasing, Congress has tabled a bill that would impose extra penalties on those seeking to harm healthcare staff.
Researchers propose solutions to underrepresentation of certain groups in genetic databases, based on two recent initiatives.