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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
OIG Work Plan Monthly Review: May 2018
From - G2 Compliance Advisor
Of the seven new Work Plan items, none directly impact labs and lab services. However, one item on Medicare Part B reimbursement of outpatient cardiac and…
Medicaid Fraud: Enforcement Continues to Trend Down as Labs Drift Deeper into the Background
From - National Intelligence Report
Last month, the OIG published its annual summary of Medicaid Fraud Control Unit (MCFU) activity for FY 2017. Here is a summary of the key findings, trends and…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
While M&A activity in the wider healthcare industry is heating up deal making in the diagnostics space remains relatively light, not so much in terms of volume but…
New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
Genetic Risk Score Could Improve Diagnosis of Atrial Fibrillation
From - Diagnostic Testing & Emerging Technologies
A genetic risk score (GRS) may identify patients at highest risk for developing atrial fibrillation (AF), according to a study published…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Fluidigm, Qiagen and MNG Laboratories launched multiple products. Here's a rundown of the key diagnostic product launches from late March through mid-April…
CDC Receives Funding to Expand Laboratory Harmonization Efforts
From - Diagnostic Testing & Emerging Technologies
The FY 2018 omnibus appropriations bill, passed by Congress in late March, included a little noticed provision that could ultimately bring significant changes to the laboratory industry…