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Elizabeth Holmes, prosecutors trade accusations over destroyed evidence

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]Ex-Theranos CEO Elizabeth Holmes through her lawyers is blaming prosecutors’ “investigative failure” for the loss of a company database that would have shown the level of inaccurate blood-testing results.

In a filing yesterday, Holmes’ lawyers claim that in the absence of information in the Laboratory Information System (LIS) database, the judge should not allow jurors to hear anecdotal stories from medical professionals and the general public about erroneous Theranos test results.

“The reason that the government has built its case on this teetering card house of irrelevant evidence is that it lost — or, worse, did not want to analyze preindictment — the actual evidence of testing results in this case,” Holmes’ lawyers said.

Prosecutors have claimed that Therano…

DTW Podcast – Tale of Two CEOs – How Tim Herbert led Inspire to an IPO; Where Rob Bodor wants to take Protolabs

Inspire Medical CEO Tim Herbert never set out to be a CEO. Yet, he spun of a promising sleep apnea technology out of Medtronic and assembled a team that not only went public, but helps hard-to-treat apnea patients live healthier lives through better sleep.

Oh, and the electrical engineer turned startup-CEO took the medtech public in 2018. Listen to this episode to hear how Inspire management worked with the FDA, payers and public investor to build a burgeoning neuromed giant.

Co-host Tom Salemi also talks to Rob Bodor, the incoming CEO at Protolabs. Bodor succeeds the highly successful Vicki Holt who built the manufacturing company into an acquisitive powerhouse. Hodor shares what’s next for the company.

Co-cost Chris Newmarker, executive editor of life sciences at MassDevice, unveils this week’s Newmarker’s Newsmakers featuring news from Thermo Fisher Scientific, Mainstay Medical, Theranos, Butterfly Networks and Zimmer Biomet’s …

Elizabeth Holmes’ need for cash, clothes, travel just like other CEOs’, attorneys say

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]Ex-Theranos CEO Elizabeth Holmes has set out to prove that the lure of wealth and fame did not lead her to commit fraud with her now-defunct blood-testing company.

Attorneys for Holmes filed dozens of briefs this week seeking to refute prosecutors’ claims that Holmes’ desire for recognition and wealth allegedly motivated her to lie about the capabilities of Theranos’ technology to detect disease through one drop of blood.

In a motion filed Jan. 8, prosecutors said that Holmes having allegedly “gained a variety of tangible and intangible benefits from the fraud tends to show that she intended to defraud in order to obtain those benefits. Similarly, Defendant’s desire to retain her wealth and status created a powerful motive for defendant to continue and conceal her fraud.”

Holmes&…

Medtechs can’t set digital strategies aside – DTW Podcast

Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck.

In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices:

Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical, says new medtech tools must be connected to provide maximum benefit. In a separate interview on the podcast, Mark Toland, the former CEO of Corindus Vascular Robotics, says medtech companies moving into the surgical robotics space are advancing the model by building digital infrastructures around the surgical system. “Now they’re thinking about the data integration work, they’re thinking about how that translates into artificial intelligence over time,” he said. Also in this podcast, Kal Patel, the CEO and co-founder of BrightInsight, shares the insight he’s bringing to medtech from his pas…

Medtechs can’t set digital strategies aside – DTW Podcast

Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck.

In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices.

Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical, says new medtech tools must be connected to provide maximum benefit.

“If you’re making a device, you have to understand and build into it how it will be connected for that episode of care as as well as how it fits into the continuum of care,” Huennekens said in an interview with the DeviceTalks Weekly Podcast. “It just has to be part of the way you’re thinking.”

Verb Surgical, of course, is now part of Johnson & Johnson’s surgical robot product line, Ottava, which the company unveiled last year.

In a separate interview on the podcast, Mark Toland, the former CEO o…

Prosecutors want to present evidence of Elizabeth Holmes’ quest for wealth and fame

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]Private jet flights, luxury hotel trips, fawning media reports and hobnobbing with the world’s elite — Elizabeth Holmes’ desire for recognition and wealth allegedly motivated her to commit fraud with her now-defunct blood-testing company Theranos.

That’s a major motive argument that federal prosecutors would like to make when Holmes’ trial starts in July in U.S. District Court in San Jose, Calif.

Holmes’ attorneys are seeking to prevent the government from presenting evidence of the former Silicon Valley entrepreneur’s lavish lifestyle, arguing that it would amount to “improper emotional appeals.”

Prosecutors in a motion filed Jan. 8 said they wanted to show how Holmes benefitted from having an assistant on the company payroll who also handled personal clo…

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

The top 5 MassDevice stories of the week — September 11, 2020

From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. Bardy Diagnostics names new CEO

Kevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.

4. Drug companies say they won’t release COVID-19 vaccine until it’s ready

Executives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scienti…

Elizabeth Holmes could make a ‘mental disease’ defense in Theranos case

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

Former Theranos CEO Elizabeth Holmes is considering making a “mental disease” defense in her closely watched federal fraud trial in San Jose, Calif.

A court order filed yesterday revealed the defense strategy. U.S. District Court Judge Edward Davila granted prosecutors’ request over Holmes’ objections to have a team of two psychological experts examine Holmes over two days of videotaped sessions in order to evaluate her claims.

Holmes, according to Davila, previously notified the court about the possibility of clinical psychologist Mindy Mechanic testifying about an examination consisting of psychological testing and “structured and semi-structured interviews.”

The court order redacts mentions of what type of mental dis…

DTW Podcast: Vizient on PPE, Vicarious on VR-aided robotics and let’s all hope for pumpernickel

This week’s episode of DeviceTalks Weekly is brought to you by the later V, as in Vizient and Vicarious Surgical.

Bharat Sundaram, COO and president of Vizient, will share how the healthcare supplier is strengthening the supply of PPE for hospitals. He’ll also reveal when the company expects to see US hospitals running at pre-COVID levels. Hint: It’ll be a while.

Adam Sachs, CEO of Vicarious Surgical, tells us how the company will put a new round of capital from high-powered investors including Bill Gates and Vinod Khosla to work in developing to develop a surgical system employing robotic and virtual reality technologies. How does the start-up expect to compete with the established leaders in the robotics space?

Co-host Chris Newmarker, executive editor, life sciences, will walk us through the five biggest newsmakers on the MassDevice site involving C.R. Bard, Theranos, and Medtronic. Number one may surprise you, but given the time, perhaps …

The top 5 MassDevice stories of the week — August 14, 2020

COVID-19 continues to batter medical device companies — not to mention the world as a whole. But some of this week’s top five MassDevice stories demonstrate that medtech companies continue to innovate and ink business deals as they look toward a post-pandemic future.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. Federal appeals court rejects preemption argument from BD’s Bard

The 9th U.S. Circuit Court of Appeals handed down an important medical device preemption opinion as it affirmed a $3.6 million award against Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard in a bellwether lawsuit case over inferior vena cava filters. Read the full story.

4. Theranos founder Elizabeth Holmes’ trial to start in March

Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial will now start in Ma…

Theranos founder Elizabeth Holmes’ trial to start in March

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial will now start in March 2021 amid delays related to the COVID-19 pandemic.

Judge Edward Davila decided yesterday that jury selection will start on March 9, with opening arguments taking place around March 16 in U.S. District Court in San Jose, Calif.

It is possible that some or all of the trial may take place over video, though a lawyer for Holmes has said that it would be hard to make video work for such a large case, according to The Mercury News.

Meanwhile, Holmes through her lawyers has also been raising questions about the grand jury that returned second and third superseding indictments against her, asking whether the pandemic prevented jury selection from a fair cross-section of the …