Devices

Government Charges Theranos With Fraud

The Securities and Exchange Commission has charged Silicon Valley-based Theranos, its founder and CEO Elizabeth Holmes, and former president Ramesh Balwani with raising more than $700 million from investors through an elaborate fraud in which they exaggerated or made false statements about the company’s blood test, business, and financial performance. Theranos and Holmes have agreed to resolve the charges against them. In addition to a penalty, Holmes has agreed to give up majority voting control over the company and a reduction in her equity.

The government contends that Theranos, Holmes, and Balwani made numerous false and misleading statements in investor presentations, product demonstrations, and media articles by which they deceived investors into believing that its key product – a portable blood analyzer – could conduct comprehensive blood tests from finger drops of blood. “In truth, according to the SEC’s complaint, Theranos’ proprietary analyzer could complete only a small number of tests, and the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” a government release says.

In 2016, FDA posted a one-page Form-483 from an inspection at the troubled blood diagnostic firm, citing it for performing clinical investigations prior to obtaining IRB approval. Presumably, the inspection document is related to the company’s decision to withdraw a Zika virus blood test it had submitted for agency approval (see story). “In my mind, this was a positive interaction with the FDA, and I'm grateful for its collaborative approach,” company vice president of regulatory, quality and clinical affairs Dave Wurtz said in a statement at the time. “We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome