Preparations for the criminal trial of former Theranos executives is straining the FDA’s staff and diverting them from other duties, a lawyer for the agency told a federal judge this week, according to published reports. FDA chief counsel Stacy Amin also told Judge Edward Davila of U.S. District Court for Northern California that technological problems […]
10 medical device industry stories you need to know
From leadership changes to tax repeal to robots — lots of robots — this was a busy year for the medical device industry. Here are 10 stories in the medtech space that especially caught the eye of MassDevice and Medical Design & Outsourcing editors and readers in 2019. Next>>
Judge orders FDA, CMS to produce missing documents in Theranos case
A federal judge has ordered the FDA and the Centers for Medicare & Medicaid Services (CMS) to produce documents pertinent to the government’s criminal case against discredited Theranos founder Elizabeth Holmes. The FDA and CMS have until Dec. 31 to provide the documents, including correspondence with Wall Street Journal reporter John Carreyrou, who broke the […]
Former Theranos CEO wrangles with FDA over missing emails
As she prepares to face a criminal trial over federal wire fraud charges, discredited Theranos founder Elizabeth Holmes is arguing with the FDA over missing emails, according to media reports. Lawyers for Holmes and former Theranos president Sunny Balwani used a hearing yesterday in federal court in Northern California to criticize the FDA for failing […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. DeviceTalks is excited to announce that Tyler Shultz will be the closing keynote speaker at DeviceTalks Boston. Shultz will take attendees behind the story that […]
Report: Theranos lays off most of its remaining workforce to stay afloat
Scandal-ridden blood testing company Theranos is laying off the majority of its workforce as it looks to stay afloat and delay bankruptcy for a few more months, according to a report from the Wall Street Journal posted on Tuesday. With the new layoffs, the company is reducing its headcount from approximately 125 employees to two […]
SEC charges Theranos, CEO Holmes with ‘Massive Fraud’
The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate, […]
UPDATE: Theranos agrees to 2-year labs ban
Theranos said yesterday that it reached an agreement with the Centers for Medicare & Medicaid Services and that it will stay out of the blood-testing biz for 2 years in exchange for reduced penalties. The settlement reportedly resolves all outstanding legal and regulatory proceedings between the 2 groups, Theranos said. According to the agreement, CMS has withdrawn […]
Report: Theranos trades extra shares for vows not to sue
Theranos is looking to avoid lawsuits from investors by offering them additional shares if they promise not to sue the company, according to a Wall Street Journal report. Shares to be offered will come from CEO Elizabeth Holmes personal stake in the company, which may cause the founder to lose a majority ownership in the blood-testing […]
Failure to thrive: Lessons learned from medtech innovations that missed the mark
Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes. Fink Densford, Associate Editor No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut. […]
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