FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
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Articles and Reports
ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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
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
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
