By judeb, from the Volume XXIV, No. 7 – May 15, 2017 issue
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision to clear this system for sale earlier this month, and informed by their
By Robert Michel, from the Volume XXI NO. 8 – June 9, 2014 issue
CEO SUMMARY: West Virginia is the second state in recent years to settle claims of Medicare and Medicaid fraud filed against Calloway Laboratories of Woburn, Massachusetts. Last month, the pain management lab company agreed to pay $4.675 million to resolve that case, while not admitting liability. During the period that Calloway was alleged to have
By Robert Michel, from the Volume VI No. 14 - October 11, 1999 issue
CEO SUMMARY: In the short term, it’s Abbott Laboratories which must deal with increasingly aggressive FDA regulators. But the real story behind the story is that the FDA is stepping up regulatory oversight of the entire diagnostics industry. Abbott faces serious consequences if it cannot resolve its disagreement with government regulators about quality issues in
