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
- 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 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.
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.
After Steady Decline, Telehealth Use Surges during Omicron
When the pandemic and lockouts first began, telehealth utilization soared to unprecedented levels. But while telehealth use remains well above pre-pandemic levels, thanks in part to relaxed Medicare coverage rules, the initial wave steadily ebbed starting in May...
FDA Grants Approval to Breast Cancer Treatment and Companion Diagnostic
Certain cancer patients now have access to a new treatment option and companion diagnostic. On March 11, the U.S. Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for treating adults with deleterious or suspected...