ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
According to a recent report, digital health companies are on track to rake in $21 billion for 2022, below the 2021 total of $29.1 billion.
Continuing recent patterns, M&A deal-making in the diagnostics space was low in volume but high in impact in October.
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
The Miami-based startup has secured major in-home phlebotomy services contracts from some of the nation’s biggest lab companies.
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
An overview and general briefing on some of the most common ICD codes concerns for labs.
How to create a written policy banning retaliation for whistleblowing and for investigating retaliation complaints.
What happens when a compliance officer is the whistleblower in a qui tam retaliation lawsuit?
This useful template can be used to develop a clear written policy on time theft for your lab in order to help prevent it.