Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Hospitals Brace for, Seek to Stave Off Medicare Sequestration Cuts
Combined with rising labor costs, COVID-19, and other challenges, stakeholders say the cuts will negatively impact patient care.
LumiraDx Gets CE Clearance for Five Different Products
The UK-based diagnostics firm received CE marks for a diabetes test, CHF test, as well as an analyzer, and two COVID-19 tests.
CMS Issues First Penalties to Hospitals for Price Transparency Violations
Georgia health system hospitals are the first to be penalized for failing to update their websites or reply to agency warning letters.
Guidance for Healthcare Workers Treating Suspected Cases of Monkeypox
Experts offer advice in a recent commentary article on treating patients who may have monkeypox during the current COVID-19 pandemic.
Leveraging COVID-19 Testing Infrastructure Can Boost Diabetes Screening
A new study suggests that this is a viable idea, particularly in the context of diabetes screening in a Latinx community.
New Company Formed to Help Improve Access to Diagnostics
The creation of Global Access Diagnostics aims to expand affordable access to quality tests around the world.
OIG: Did Labs Do Enough Non-COVID-19 Testing during Pandemic?
The number of non-COVID-19 tests billed to Medicare during the pandemic has decreased compared to the six-month period before COVID-19.
Smart Inhalers May Enable Better Management of Respiratory Disorders
Inhalers and sensors that offer digital monitoring are beginning to gain FDA approval, and could solve usage issues of traditional products.
Genomic Biomarker Tests Endorsed for Early Prostate Cancer Management
Revised guidelines from the American Urological Association support limited use of the tests for certain prostate cancer patients.
FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.