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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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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”
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
New Assay Could Make Allergy Testing Easier and Less Painful
Diagnosing allergies is difficult and cumbersome. Current skin-prick tests are painful, time-consuming, and carry the chance of the patient having a dangerous allergic reaction. But a new assay from researchers at the University of Bern and Inselspital, Bern...
NIH Sees Budget Increase by $2 Billion
On March 15, President Biden signed the Consolidated Appropriations Act, 2022 into law, an omnibus bill that sets the budgets for all federal agencies for the rest of FY2022. The bill includes a $2 billion increase for the National Institutes of Health (NIH),...
New Smartphone App Encourages People to Seek Therapy for Heart Disease
Smartphone apps can already help manage many aspects of our health, from tracking physical activity to suggesting healthy eating options to monitoring heart rate. Now, a new app has been developed that predicts an individual’s genetic risk for coronary artery...
Quest and Walmart Partner to Make Consumer Lab Tests Accessible Online
Even before the pandemic, labs and major retailers have been partnering to make lab tests more accessible for consumers. Under a recently announced collaboration, Quest Diagnostics, the nation’s largest lab will work with retail giant Walmart to enable customers to...
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
Omicron Drives New Surge in National Telehealth Utilization
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One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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Breast Cancer Screening Overdiagnosis Rate Is Only 15 Percent: Study
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FDA Orders LuSys and Celltrion to Recall Unauthorized COVID-19 Rapid Tests
This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance. San Diego-based LuSys Laboratories is recalling...
How CSF Tests May Help Recruitment for Alzheimer’s Drug Clinical Trials
A recent study shows these tests may make it easier and more cost-effective to identify patients for studies of new PET treatments.
