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
Already a Subscriber? Log in Here
Lab Industry Advisor Subscription
Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
Lab Industry Advisor to the Rescue! Lab Industry Advisor provides comprehensive, up-to-date insights and analyses tailored to your needs. With expert commentary and actionable advice, you’ll stay ahead of the curve. No more sifting through endless sources—everything you need is right here!
Start your free trial today and see how Lab Industry Advisor can transform your approach. Get instant access to invaluable resources designed to keep you informed and competitive. Explore detailed reports, in-depth articles, and exclusive industry insights that help you make better decisions faster. Choose from three subscription levels tailored to fit your needs: Essential, Premium, and Elite.
Additional Business Intelligence Offerings
Clinical Diagnostics Insider
Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies
Virtual Events & Webinars
Virtual events & webinars offer a variety of solutions and strategies for dealing with key issues labs face.
Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Startup Awarded NIH Grant to Develop Endometriosis Test
OAKLAND, CA — NextGen Jane, a genomics startup generating big data for novel applications in molecular diagnostics and drug development for female reproductive disorders, announced that it has received the green light for the second phase of a Small Business...
Plugging Current Gaps in Cancer Screening Will Save Lives
...
Register
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
Potential Liability of Billing Consultants for Medicare Fraud
...
Register
Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test
On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...
Leader in Brain Health Sector Achieves Key Certification
ST. LOUIS, MO — C2N Diagnostics has earned ISO 13485:2016 certification for its quality management system. In late 2020 C2N launched the PrecivityAD™ test, an innovative blood test intended for use with patients with cognitive impairment. The test aims to help...
EC to Phase in New In Vitro Diagnostic Regulation, Starting May 26
...
Register
Could CRISPR-Based Options Be the Next Generation of COVID-19 Diagnostics?
...
Register
Scorecard: COVID-19 Rapid Test Recalls and Warnings in 2022
...
Register
Newly Identified Protein May Help Diagnose Ulcerative Colitis
An international research collaboration has discovered a potential new diagnostic marker for ulcerative colitis in a trans-ethnic analysis of Japanese and White patients. The finding could lead to the development of non-invasive, diagnostic blood test to both...
