The new guidelines address issues with false negatives and positives from POC testing for fertility and reproductive health.
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
POC tests offer speed and simplicity, but are less reliable than tests performed in labs.
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
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