Another medtech reports a cybersecurity incident

LivaNova (NASDAQ: LIVN) + says it’s the latest victim of a cybersecurity incident.

The London-based device developer disclosed the cybersecurity incident in a Securities and Exchange Commission filing this week, saying the incident disrupted portions of its information technology systems and business operations.

“Promptly after detecting the issue, the company began an investigation with assistance from external cybersecurity experts and is coordinating with law enforcement,” LivaNova said in the filing. “The company continues to assess what information and systems were impacted and is executing its incident response plan, including implementing remediation measures to mitigate the impact of the incident.”

“The company has and will continue to take actions to remediate the issue, such as taking certain systems offline,” the company continued.

LivaNova said it expe…

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Henry Schein’s cybersecurity incident updates offer guidance for others

Henry Schein’s ongoing response to its cybersecurity incident offers lessons for how other device developers and manufacturers should keep investors and customers in the loop under similar circumstances — and could help device designers and engineers understand how much (or little) information they may get from cyberattacked suppliers.

This week, a ransomware group known as BlackCat/ALPHV said it encrypted Henry Schein’s systems and stole 35 TB of “sensitive data,” threatening to start releasing “internal payroll data and shareholder folders.” Henry Schein has not publicly acknowledged that group’s claims.

Henry Schein appears to be the first company on the Medtech Big 100 to disclose a cybersecurity incident since the new Securities and Exchange Commission regulations took effect. (These regulations are different than the FDA’s new cybersecurity requirements for developers and manufacturers of cyber devices.)

The new SEC …

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ZimVie discloses executive pay and severance for first C-suite exit

ZimVie executive pay is public for the first time a year after the spine and dental device developer spun off from Zimmer Biomet.

Westminster, Colorado–based ZimVie (Nasdaq:ZIMV) disclosed pay for its top executives in late March ahead of the May 12 inaugural annual meeting of shareholders. Investors will weigh in on the executive pay packages for the first time in an advisory “say-on-pay” vote.

One of those executives is no longer with ZimVie. In annual proxy filings with the Securities and Exchange Committee, the company said former SVP and Chief Human Resources Officer David Harmon “separated from the company” on Jan. 13, 2023.

Harmon joined ZimVie in September 2021 and was announced as part of the leadership team before the spinoff launched in March 2022. He was previously the chief people officer at Gannett; he now lists himself as self-employed on his LinkedIn profile.

The proxy filing doesn’t say why Ha…

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Boston Scientific whistleblower launches corruption investigation

Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam.

Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission.

“In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam. The company is cooperating with government agencies while investigating these allegations,” the company said in its second-quarter 10-Q filing, dated Aug. 4.

More information about the allegations was not available from the filing or a Boston Scientific spokesperson reached by Medical Design & Outsourcing today. The news was first reported by the Wall Street Journal.

The Foreign Corrupt Practices Act (FCPA) was enacted in 1977 to stop companies and their employees or agents from bribing foreign officials to win or…

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Johnson & Johnson faces another ballot battle on racial equity audit

Johnson & Johnson is fighting another shareholder proposal for an independent racial equality audit of the company.

New Brunswick, New Jersey–based J&J (NYSE:JNJ) defeated a similar measure at last year’s annual meeting of shareholders, though the vote was far from a landslide. The company also unsuccessfully petitioned the U.S. Securities and Exchange Commission to keep it off the ballot.

Now, an independent audit is again up for consideration at the April 28 annual meeting after surviving another J&J appeal to the SEC.

Proponents of the audit cite ongoing controversies over talcum powder allegedly marketed to minorities. They also point to the J&J Political Action Committee’s financial support of Republican members of Congress who voted to overturn President Joe Biden’s election after insurrectionists stormed the U.S. Capitol.

Get the full story at our sister site, Medical Design & Outsourcing. Read more

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Medtronic faces longer road to renal denervation

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) will continue the Spyral clinical study of its Symplicity renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early.

Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference in early November, pending an interim analysis in October.

Significantly positive results would have advanced Medtronic’s efforts for FDA approval. But the independent data safety monitoring board conducting that analysis — meant to end trial enrollment if results are significantly better or worse than expected — recommended that Medtronic continue enro…

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SeaSpine warns of COVID-19 hit to surgical revenue

SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business.

Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout the United States.”

“Throughout the third quarter of 2021, and most acutely starting in August, spine surgery procedure volumes were negatively impacted in many areas of the United States, including in Florida and Texas, where SeaSpine derives a meaningful portion of its revenue, due to cancellations and/or postponements of procedures as a result of the increased cases and transmissibility of COVID-19 and because hospitals and other surgical centers were experiencing staffing shortages,” the company said in the SEC disclosure.

SeaSp…

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