Theranos Trying to Rebuild Despite Legal Actions
Theranos has hired new executives and created a quality and regulatory control committee to appeal sanctions from the CMS.
Healthcare technology company Theranos, Inc recently hired 2 executives and created a new board committee whose priority will be quality and regulatory control.
This decision is in part due to a recent civil lawsuit alleging the company is responsible for poor health outcomes for patients who received invalid blood tests. Regulators decided to revoke the company’s laboratory licenses in California, and banned CEO Elizabeth Holmes from the blood-testing business for at least 2 years, according to The Wall Street Journal.
But, this was not an immediate action, and the company still has time before the decisions go into effect. Before the ban does go into effect, the company is hoping to resolve ongoing issues and appeal any decisions made.
A new chief compliance officer and a new vice president for regulatory and quality were appointed, and Theranos also added a compliance and quality committee to its board, according to the article.
The new vice president of regulatory and control will obtain FDA clearances and approval, market products, and will oversee regulatory matters, medical device quality systems, and the clinical affairs workforce.
In addition to these sanctions from the US Centers for Medicare and Medicaid Services, Theranos is also being questioned about its honesty with investors and regulators, and whether or not the company mislead those parties, the article concluded.