Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs

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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.

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Insight for every clinical laboratory

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Exclusive, in-depth monthly reports

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Expert analysis & technology advice

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Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies

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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
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Latest Articles

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.

3 Thoughts on the FDA’s Final LDTs Rule

By Rachel Muenz | May 14, 2024

Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs

Shot of a young scientist going through paperwork in a lab

US Government Launches Nationwide Test-to-Treat Initiative

By Rachel Muenz | Mar 15, 2022

Recently unveiled program aims to ensure easy access to COVID-19 treatments for all eligible Americans.

A young male doctor sitting with two young female patients hands one patient a bottle of pills. All are masked due to the COVID-19 pandemic.

Physicians Get a Break on 2021 MIPS Payment Adjustments

By Glenn S. Demby | Mar 15, 2022

Just as it seemed like physician practice patterns were getting back to normal, the late-year Omicron surge skewed the Merit-based Incentive Payment System (MIPS) quality data for 2021. With that in mind, the Centers for Medicare & Medicaid Services (CMS) has...

A closeup of someone typing with a calculator nearby.

Potential New Test Could Diagnose Lyme Disease Sooner

By Tufts University | Mar 15, 2022

For scientists and clinicians alike, one of the Holy Grails for successfully treating and curing Lyme disease is developing tests that identify the disease sooner, show when people are cured of infection, and can diagnose reinfection. Now, researchers at Tufts...

A closeup of a doctor removing a tick from a patient's hand.

FDA and Industry Reach Agreement on MDUFA V Medical Device User Fees

By Glenn S. Demby | Mar 14, 2022

For a while, it looked like the FDA and medical tech industry might not cut a deal on the next round of medical device user fees under the Medical Device User Fee Amendments (MDUFA V) before the current agreement expires in September. But last week, the agency...

A photo illustration of a hand reaching out to various medical-related icons to represent medical technology

Singleron Extends Reach outside of China with Acquisition of Proteona

By Rachel Muenz | Mar 14, 2022

Last week, Chinese genomics company Singleron Biotechnologies, which develops single-cell multi-omics platform technologies and helps translate them to the clinic, announced it had acquired Proteona Pte. Ltd. Based in Singapore, Proteona is also focused on the...

an illustration of human cells in various shades of blue and purple

Home-Based Flu Tests as Accurate as Rapid In-Clinic Options

By University of Washington School of Medicine | Mar 14, 2022

Home-based, self-administered tests for influenza are comparable in accuracy to rapid diagnostic tests in clinical settings, according to a recently published, peer-reviewed study. “Home tests are a valuable tool to support the management of influenza and other...