Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to...

Clinical Pathology Laboratories Still Waiting for Molecular Test Payments, Speakers Report at First Day of Executive War College

For more than a year Medicare contractors have been developing payment rates for the 114 molecular tests and without setting rates, they cannot make payments. New Orleans, Louisiana, April 30, 2013—Getting paid for molecular test claims submitted under the new molecular CPT codes was a subject of high interest on the opening day of the Executive War College. Most clinical laboratories and pathology groups performing molecular tests nationwide report that they have not been paid for invoices...
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