Week in Review: Cautionary fraud case | Software risk recommendations | State-level policy push

Dear LabPulse reader,

Our most-read news this week offered advice and updates from different quarters on laboratory business. First, we reported on Boston law firm Robinson and Cole's take on a complex fraud case in the District of Massachusetts. The company called it “a cautionary tale to relators about the significance of their own conduct."

Next to catch readers’ attention was an article on a new report from the International Medical Device Regulators Forum (IMDRF). The report outlined a general strategy for characterizing software-specific risks in the use of software as a medical device (SaMD). It is intended to complement existing risk-management programs in helping users develop approaches.

Also in the Top 5, medtech industry advocate AdvaMed released its “Patients First Agenda." With patient advocacy organizations and professional medical societies, AdvaMed plans to push for state-level policymaking in 2025. The recommendations are aimed at improving access to healthcare, including eliminating high out-of-pocket costs for certain diagnostics, increasing coverage for biomarker testing, ensuring access to opioid testing in emergency care settings, and reducing barriers to colorectal cancer screening. 

On the regulatory front, U.S. Food and Drug Administration (FDA) clearances on an Alzheimer’s test and an IV therapy were noteworthy this week. Beckman Coulter received breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 assay, designed to identify the amyloid pathology of the early stages of Alzheimer's disease. Meanwhile, Eisai and Biogen's Alzheimer's disease drug Leqembi was approved for a monthly maintenance dose schedule after the initial 18-month treatment course.

Rounding out our most-read stories of the week was the announcement that Quest Diagnostics completed its acquisition of outreach lab assets from hospital network University Hospitals, a deal first announced in July 2024. 

Thanks for reading.

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