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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
LabCorp Acquires Pathology, Inc.
By Ron Shinkman, Editor, Laboratory Industry Report LabCorp will acquire a significant presence in women's health assays. The North Carolina-based LabCorp announced the acquisition of Pathology, Inc. on Dec. 10. Terms of the transaction were not disclosed. The lab...
Quest to Manage Barnabas Health’s Hospital Laboratories
By Ron Shinkman, Editor, Laboratory Industry Report Quest Diagnostics, which has been extending itself more into the operation of hospital laboratories in recent years, has just inked a deal to manage the labs owned by the largest hospital operator in its home...
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…
Whistleblower Claims Lead to Big Settlements for Pathology Group and Laboratory
By Kelly A. Briganti, Editorial Director, G2 Intelligence Two separate False Claims Act cases initiated by whistleblowers have resulted in settlements for a North Carolina pathology group and a Wisconsin laboratory, its founders and a related company. In the first...
Philanthropy Giants Funding Medical Research
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Facebook founder Mark Zuckerberg grabbed headlines this week because of the letter he and his wife wrote to their newborn daughter announcing they will give 99 percent of their Facebook shares...
Transgenomic Sells Genetic Test Business To Japanese Company
By Ron Shinkman, Editor, Laboratory Industry Report Struggling Transgenomic has exited the genetic assay business. The Omaha, Neb.-based company announced this week it had sold its genetic assays and platform unit to ADSTEC Corp., a Japanese company. The sales...