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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
Blue Cross and Blue Shield of Minnesota Files Lawsuit Against GS Labs
EAGAN, MN — Blue Cross and Blue Shield of Minnesota (Blue Cross) announced on March 1 that it is taking legal action against COVID-19 testing laboratory GS Labs, LLC (GS Labs) to recover more than $10 million in overpayments made since the start of the pandemic....
Be ‘Recall Ready,’ FDA Urges Companies
SILVER SPRING, MD — On March 3, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is...
Labs in Court Weekly Roundup
Court cases involving the lab and health care industries from this past week and a half have centered mostly on fraud. In addition to those cases, a former doctor was charged for unlawfully distributing opioid pills and the U.S. Department of Justice (DOJ) and...
Liquid Biopsy Global Sales Expected to Hit $26.2 Billion by 2030
A new report projects that the worldwide market for liquid biopsy will grow from $7.1 billion in 2020 to $26.2 billion by 2030
New Microchip Could Lead To Home-Based Prostate Cancer Tests
Associate professor Kazuhiro Takahashi and Tomoya Maeda (a second-year master's student) and other members of the Department of Electrical and Electronic Information Engineering at Toyohashi University of Technology have developed a semiconductor sensor capable of...
CT Provides Safe, Accurate Diagnosis of Coronary Artery Disease
Is cardiac computed tomography (CT) as reliable as catheterization in patients with suspected coronary artery disease? Under the leadership of Charité – Universitätsmedizin Berlin, researchers from 31 European clinical institutions worked together to address this...
Monitoring Tech Dominates Recent Breakthrough Device Designations
In a quick look at U.S. Food and Drug Administration approval activity from Feb. 23 to March 7, monitoring tech makes up most of the latest breakthrough device designations achieved. Two of the three breakthrough designations announced over this period include...
Standard for Pulmonary Function Tests Gets an Update
NEW YORK, NY — March 2, 2022 — In the latest update to the pulmonary function tests technical standard series, the American Thoracic Society and European Respiratory Society address the uncertainty around the interpretation of the tests which are essential in...
Single Test for Over 50 Genetic Diseases to Accelerate Diagnosis
A new DNA test, developed by researchers at the Garvan Institute of Medical Research in Sydney and collaborators from Australia, UK, and Israel, has been shown to identify a range of hard-to-diagnose neurological and neuromuscular genetic diseases quicker and...
Healthy Market Outlook for Smart Inhalers, Report Says
Smart inhalers could be a key solution to the drawbacks of current options on the market, which many people with respiratory disorders do not use correctly. According to analysis released by Persistence Market Research at the end of 2021, the smart inhalers...
