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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
The Craze Is Over but Healthcare SPAC Deals Remain Alive and Well
A hot trend in capital raising for the healthcare and life sciences industries only two years ago, SPAC deals have petered out, but are far from dead.
Join Us April 27th to Discuss How We Can Improve Our Content
Webinar will give you the chance to learn about recent changes at G2 and ask the editorial team any questions you may have.
Congress Strikes Deal on COVID-19 Response Funding
The good news: Congressional negotiators have cut a deal for $10 billion in additional funding for COVID-19 testing and vaccination in the US. The bipartisan package will enable the federal government to purchase more therapeutics, tests, vaccines, and other...
Castle Biosciences Set to Acquire AltheaDx
In a key deal announced this week, Castle Biosciences signed a definitive agreement to acquire commercial-stage molecular diagnostics company AltheaDx, which specializes in pharmacogenomics testing services focused on mental health. In a statement released April 4,...
Medicare Patients Can Now Get Free OTC COVID-19 Tests
Medicare patients can now get over-the-counter (OTC) COVID-19 tests free of charge, CMS announced on Monday. From now through the end of the public health emergency, individuals with Medicare Part B coverage, including those in Medicare Advantage plans, can get up...
Labs in Court Weekly Roundup
Of the enforcement actions announced last week involving laboratories and the health care industry, the majority of cases involved urine drug testing. More specifically, three cases relating to urine drug testing involved an illegal kickback scheme as well as...
Explanatory AI Benefits Doctors Diagnosing Fetal Heart Disease
Researchers from the RIKEN Center for Advanced Intelligence Project (AIP) and colleagues have tested AI-enhanced diagnosis of fetal congenital heart disease in a clinical setting. Both hospital residents and fellows made more accurate diagnoses when they used a...
Radiopharmaceutical Gets FDA Approval for Treatment of Prostate Cancer
Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The radiopharmaceutical medication, from Novartis...
Global Aspiration & Biopsy Needles Market to See Strong Growth
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.
