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

Start your Free trial Today

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.

Essential

Insight for every clinical laboratory

Subscribe today for updates on key developments in the clinical lab industry.

Premium

Exclusive, in-depth monthly reports

Subscribe today for additional insider reports about important lab trends.

Elite

Expert analysis & technology advice

Subscribe today for quarterly expert analysis & Clinical Diagnostics Insider.

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

By Rachel Muenz | Oct 10, 2024

Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”

A closeup of someone looking at legal documents at a desk

New FDA LDTs Guidance Offers Useful Summary, But Questions Remain

By Rachel Muenz | Jun 27, 2024

Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details

A wooden stamp lies on a red surface next to stamped white

CMS Slated to Close Change Healthcare Payment Program

By Centers for Medicare & Medicaid Services | Jun 21, 2024

Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July

A medical billing professional sits at a computer with two monitors and reads paperwork, illustrating a healthcare reimbursement concept.

Labcorp Completes Acquisition of Personal Genome Diagnostics

By Labcorp | Feb 23, 2022

BURLINGTON, NC — Labcorp, a leading global life sciences company, announced Feb. 21 that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products....

Digital screen with DNA strands and data background. Double helix structure. Nucleic acid sequence. Genetic research. 3d illustration.

Startup Awarded NIH Grant to Develop Endometriosis Test

By NextGen Jane | Feb 23, 2022

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...

Endometriosis, virtual model of the uterus, close-up. Woman suffering from menstrual pain, while sitting on bed.

Plugging Current Gaps in Cancer Screening Will Save Lives

By Glenn S. Demby | Feb 22, 2022

...

This content is for Paid Members only.
Register

Already a member? Log in here

A technologist sets up a mammogram machine while a patient in a hijab looks on.

2021 Was a Breakthrough Year for Breakthrough Devices Program

By Glenn S. Demby | Feb 22, 2022

The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.

A hospital room full of a variety of medical devices with a HUD overlay to symbolize breakthrough medical devices.

Potential Liability of Billing Consultants for Medicare Fraud

By Glenn S. Demby | Feb 22, 2022

...

This content is for Paid Members only.
Register

Already a member? Log in here

Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test

By Glenn S. Demby | Feb 22, 2022

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...

Pcr well plate on 96 well microplate with biological samples.

Leader in Brain Health Sector Achieves Key Certification

By C2N Diagnostics | Feb 22, 2022

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...