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FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
Congress Passes New FDA Medical Devices User Fee Amendments (MDUFA V) Deal
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
Clinical Lab Pays Big to Settle UDT False Claims Allegations in NC
In this week’s enforcement roundup, Radeas reaches a settlement with the State of North Carolina after alleged improper billing.
Holmes Wins Sentencing Delay and May Get a New Trial
Judge Edward Davila postponed sentencing for at least one month to consider new evidence of possible government misconduct.
Lab Institute Who’s Who: Cameron S. Hill
Learn more about the legal remedies potentially available to clinical labs who have not been fully paid for COVID testing by insurers.
Lab Institute Who’s Who: Jane Hermansen
Learn about how the COVID-19 pandemic has shaped the clinical lab industry and how those lessons can lead to better labs for the future.
Radiology Services Company President Gets 15 Years behind Bars for Fraud
In addition to the prison sentence for the x-ray-related fraud scheme, the company president must also pay nearly $2 million in restitution.
COVID-19 Testing Lab Can’t Sue Insurer for Violating CARES Act Obligations
A significant new court ruling from a Minnesota federal court draws a line on how far labs can go when insurers short-change them.
New Insight into Deaths of US Cancer Patients Due to COVID-19
Recent study provides new details on how COVID-19 impacted cancer deaths in the US early in the pandemic and which groups were most affected.
Qiagen Enters Neurology Space with Parkinson’s CDx Collaboration
The developer of NGS-based companion diagnostics targets the growing neurology biomarker market.