FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
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FDA Watch: Truvian Health Receives Initial FDA Clearance for 34-Test Platform
San Diego-based healthcare diagnostics company is trying to succeed where Theranos failed
FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
Congressional Leaders Query FDA and CMS about Theranos
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FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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FDA Workshop Addresses Security of Medical Devices
From - G2 Compliance Advisor
The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of wireless, internet-and network-connected devices and…
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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FDA Details Oversight of Medical Applications On Smart Phones and Tablets
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Final FDA Guidance on RUO, IUO Products Raises Compliance Concerns for Labs
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