Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Theranos in Court: Balwani Gets Nearly 13 Years in Prison
After being convicted on all charges he faced, the former Theranos COO was sentenced to 12 years, 11 months on Dec. 7.
Weekly Enforcement Report: Jail Time for Diagnostic Testing Facility Owners
Co-owners sentenced to three years each for paying millions in kickbacks for referrals to their Brooklyn-based facilities.
OIG Steps Up Enforcement Activity, but Recovery Numbers Still Lag
While civil actions, criminal actions, and exclusions are up, the increased activity isn’t yet reflected in total recoveries.
Which Blood Tests Are Best at Early Alzheimer’s Detection?
A recent study led by a team at the University of Gothenburg shows that multiple biomarkers could ID the disease even in people with no symptoms.
Memo to Lab Compliance Managers: Set Your Goals for 2023
Learn why this is the perfect time of the year to mobilize your board members.
Q3 Lab Company Earnings Take a Hit
A decline in COVID-19 testing demand, along with a challenging economy, made for a difficult quarter for diagnostics companies.
Amazon Makes Third Attempt to Disrupt Healthcare Business
Having twice failed to disrupt health care, Amazon opts for a different strategy this time around—and it may just work.
December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
How to Use Mobile Apps to Optimize T&E System Performance in Labs
Automating travel and expense significantly improves performance, but adding mobility takes such improvements to a much higher level.
A Brief Look at the COVID-19 Saliva Testing Global Market
The recent FDA approval of an OTC test shows that COVID-19 saliva testing may be poised for bigger and better things in the years ahead.
