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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
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.
Balwani Lawyers: Elizabeth Holmes Entirely to Blame for Theranos
"Elizabeth Holmes, not Sunny, founded Theranos and built Theranos." So spoke defense counsel Steve Cazares in his opening statement in the trial of Theranos co-founder Ramesh “Sunny” Balwani, which resumed earlier this week. Pointing the finger at the other partner...
FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests
With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes...
What’s New with G2? Brand Update and Q&A Session
Get an update on G2 Intelligence, learn what key lab industry stories our editors are following, and ask any questions you may have.
Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies
CMS has published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments deficiencies for the previous year.
FDA Getting More Muscle to Take Unproven AA Drugs Off the Market
Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately...
