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...

Theranos Selects Phoenix Metro to Plant Its Flag and Enter the Competitive Market for Clinical Pathology Laboratory Testing

As predicted by Fortune Magazine in its coverage of Theranos, with its expansion into Phoenix, the lab company is getting its closest scrutiny from pathologists and medical technologists Recent developments in Phoenix, Arizona, make it clear that Theranos has chosen this desert metropolis to be the launching pad for its much-publicized proprietary clinical laboratory testing business. The highly-secretive company, which claims to have more market value than either Quest Diagnostics...

Wall Street Journal Writes about Federal Investigation of Health Diagnostic Laboratory and Certain Specialty Medical Lab Test Companies

Did “processing fees” paid by certain clinical laboratory companies to physicians represent an inducement that violated federal anti-kickback laws? Once again, allegations of fraudulent practices at a fast-growing clinical laboratory company have made national headlines. This time it was a front-page story in The Wall Street Journal (WSJ) that last week discussed the controversy surrounding Health Diagnostic Laboratory (HDL) of Richmond, Virginia. According to the WSJ story, federal healthcare...

Ratings Agencies Go Negative on Not-for-Profit Hospitals for 2014; Their Projections Signal Fewer Resources for Hospital-based Clinical Laboratories

This hospital industry sector is expected to achieve lower growth rates and less revenue and are likely to reduce operating budgets for medical laboratories Tough financial times are ahead for not-for-profit hospitals, according to the projections of multiple rating agencies. Financial analysts attribute this to an extended period of massive and disruptive change. This is not good news for hospital-based clinical laboratory managers and pathology groups. Big Three credit-rating agencies...

Hospitals Mine Clinical Data to Help Reduce Costs and Avoid Readmissions, Creating Opportunities for Clinical Laboratory Pathologists to Contribute to Improved Patient Outcomes

Medical laboratory test data is one cornerstone of this data mining activity and pathologists are well-positioned to take a more prominent role in helping clinicians use lab tests more effectively Data mining has arrived at many hospitals and health systems. The goal is to mine large quantities of clinical data to identify useful patterns that can guide clinicians to intervene with specific patients. This trend creates a big opportunity for pathology informaticians to step forward and...
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