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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
New Study Supports Accuracy of Diagnoses from Video Visits
Video telehealth during the early period of the COVID-19 quarantine was actually highly effective in providing accurate diagnoses, research shows.
Polygenic Risk Scores Can Predict Chance of Sudden Cardiac Death
Recent study shows scores capable of assessing genetic risk of coronary artery disease can also ID those at high risk of death.
ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort
Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.
Sutter Health Pays Millions to Settle Improper Billing Claims
The healthcare services provider will be on the hook for $13 million for alleged improper billing of lab tests.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
CMS to Create New Breakthrough Device Medicare Coverage Rule
The rule would ensure Medicare coverage of newly approved breakthrough devices, but have stricter evidence standards.
Healthcare Providers Frequently Targeted in Racial Incidents
A new analysis by ECRI shows that, while patients are also common targets, providers had to face racist behavior or comments most often.
Blood Test Can Reliably Predict Patient Risk of Long COVID
Research offers new evidence that a test targeting blood-based biomarkers can predict someone’s risk of developing long COVID.
Lab Institute Who’s Who: Mason Shaw
Learn more about how to tackle the key staffing challenges facing diagnostics laboratories today and tomorrow.