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…

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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…

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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 …

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Theranos founder Elizabeth Holmes is questioning grand jury selection process

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]

Prosecutors are asking a federal judge to mostly deny ex-Theranos CEO Elizabeth Holmes’ request to inspect grand jury selection records.

Holmes, according to the prosecutors’ July 31 response to Holmes’ July 30 motion, is adopting a strategy of other defendants indicted during the COVID-19 pandemic — to suggest without basis that was the grand jury that returned second and third superseding indictments against her was not selected at random from a fair cross-section of the community.

“Defendant Holmes is not entitled under the [Jury Selection and Service Act] to the majority of the materials she seeks because such materials are not necessary to allow her to assess whether to move to stay proceedings or dismiss the indictment. …

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Theranos founder Elizabeth Holmes is questioning grand jury selection process

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]

Prosecutors are asking a federal judge to mostly deny ex-Theranos CEO Elizabeth Holmes’ request to inspect grand jury selection records.

Holmes, according to the prosecutors’ July 31 response to Holmes’ July 30 motion, is adopting a strategy of other defendants indicted during the COVID-19 pandemic — to suggest without basis that was the grand jury that returned second and third superseding indictments against her was not selected at random from a fair cross-section of the community.

“Defendant Holmes is not entitled under the [Jury Selection and Service Act] to the majority of the materials she seeks because such materials are not necessary to allow her to assess whether to move to stay proceedings or dismiss the indictment. …

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The top 5 medtech stories of the week — July 24, 2020

COVID-19 is surging back in the U.S., new jobless claims are up, but MassDevice’s most-read stories this week were mostly optimistic.

That’s the takeaway from our inaugural MassDevice Top Five — a weekly recap of the most-read stories on MassDevice, the online business journal of the medical device industry. 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. Better than expected results from Edwards Lifesciences

Officials at Edwards Lifesciences (NYSE:EW) had warned that it was going to be a tough Q2 amid the COVID-19 pandemic. Sure enough, it was. But the Irvine, Calif.–based artificial heart valves and hemodynamic monitoring company results still beat Wall Street expectations — with the company even upping its earnings guidance for the year. “Irrespective of the unpre…

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Theranos founder Elizabeth Holmes’ trial likely won’t take place until next year

Elizabeth Holmes back during her black turtleneck days at Theranos — in 2014 [Photo by Max Morse for TechCrunch TechCrunch – TechCrunch Disrupt San Francisco 2014, CC BY 2.0]

A federal just in California this week signaled that the trial of ex-Theranos CEO Elizabeth Holmes and president Sunny Balwani likely won’t happen until next year.

The COVID-19 pandemic had already caused Judge Edward Davila to push the trial start date back to October. Davila indicated during a July 20 hearing held over Zoom that an October start was not going to happen, according to media reports.

Holmes’ lawyers used the Monday hearing to argue that the expansive nature of the government’s evidence — millions of documents and 150 or more witnesses — made the case difficult to defend against.

Davila declined to exclude evidence or witnesses but said prosecutors need to provide Holmes with more witness…

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Theranos’ Balwani seeks trial delay, Holmes objects to new charges

Former Theranos president Sunny Balwani has asked a federal judge to postpone his trial on fraud charges until April 2021 and to allow him to renew his passport so he may visit his sick mother in India.

Federal prosecutors agreed to the trial postponement, according to a court filing. No indication was given of their stance on the passport request. Balwani’s mother is in rapidly declining health and was hospitalized on April 29, according to a court filing.

The trial of Balwani’s co-defendant, Theranos’ ex-CEO Elizabeth Holmes, was recently moved from July 28 to Oct. 27, 2020, due to concerns over the COVID-19 pandemic. At the time, federal prosecutors told the court that they would like to file a superseding information containing two wire fraud counts relating to patients who paid for Theranos testing, widening the timeframe of the allegations and including company investors as fraud victims.

On Friday, Holmes’ attorney told the…

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