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
Dx Deals: Labcorp Buys Select Assets of Empire City Laboratories
The national lab giant swiftly merged Empire City’s operations into its own
Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
OIG Report on Lab Testing Should Prompt Compliance Review
Genetic testing now accounts for 43 percent of all Medicare Part B laboratory spending
Overturning of Molecular Test Coverage Denials Varies Widely, According to UCSF Study
Research into independent medical review data in four states show payers’ internal policies affect rates of overturns
Dx Deals: Fulgent Genetics Scores Two Laboratories in a Single Deal
It is acquiring Bako Diagnostics and StrataDx for a combined $55.5 million
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
Up Next for Labs: PAMA Reporting Window Opens May 1
Cuts to reimbursement rates under PAMA have been pushed back again by Congress, this time to January 2027
PAMA Delay Proposed Until 2027 Under a New Federal Spending Bill
However, attorney Danielle Sloane urges labs to be proactive about potential PAMA reporting requirements on Jan. 31 if the bill doesn’t pass quickly
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
Dx Deals: Seeking Expanded MRD Testing, Natera Acquires Foresight Diagnostics in $450M Deal
Agreement is part of the Natera’s aggressive growth model as it strives to turn a profit
ACLA Head Pushes RESULTS Act Passage During House Subcommittee Testimony
Better clinical laboratory test data reporting would allow ‘Medicare rates to be more appropriately set,’ says Susan Van Meter
