October 2023 Labs in Court
Recent cases involve charges and judgments related to COVID-19 add-on tests, genetic testing fraud, and kickbacks.
Author Information
Glenn S. Demby
Glenn S. Demby is an award-winning journalist with a track record of telling business professionals who aren’t lawyers how to comply with the parts of the law that affect their day-to-day operations. He has expertise in numerous aspects of law including employment, labor, health care, tax, payroll, benefits, and education. He won the Specialized Information Publishing Association’s editorial excellence award four years in a row. A graduate of Columbia University School of Law, he practiced as a corporate lawyer on Wall Street prior to his career as a business-to-business journalist. In addition to overseeing the content of the four G2 Intelligence monthly briefings, he contributes to the daily Laboratory and Pathology Insider.
Posts by the Author
The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
Is a Newly Proposed Rule Meant to Stop Healthcare Consolidation?
The new rule put forth by the FTC and DOJ would make mergers and acquisitions much more difficult to achieve.
Compliance Perspectives: How to Comply with the CMS 60-Day Overpayment Repayment Rule
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 Labs in Court
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
DX Deals: Teaming with Google Leads to WGS Success for PacBio
A strategic partnership with Google enables more accurate whole genome sequencing with machine learning.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
The Top 10 Clinical Lab Acquisitions of 2023
Seven months into the year, there were already four reported deals valued at over $1 billion in 2023, as many as in all of 2022.
Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.
