St. Jude Hacking-Risk Allegations: US FDA Continues Assessment, As Firm Files Lawsuit

While conflicting reports have surfaced regarding the veracity of allegations from a short-seller that a significant number of St. Jude cardiac rhythm management devices have serious cybersecurity flaws, FDA says plans to complete an initial assessment of the allegations soon. The Minnesota device-maker, meanwhile, says it is suing the short-seller for disseminating false information.

MT1609_HackerWallOf Money_1200x675

[Editor's note: This article has been updated to clarify that FDA plans to complete an initial internal assessment of the Muddy Waters' allegations in the coming weeks, and that the agency will communicate findings publicly if warranted. The article has also been updated to state that ICS-CERT, not FDA, assigns case tags when warranted and that the 30-day clock for manufacturers to conduct an initial assessment of potential cybersecurity vulnerabilities is a draft guidance proposal, not a requirement.]

US FDA says it continues to investigate allegations by investment research firm that St. Jude Medical Inc. cardiac devices...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

More from Medtech Insight

Abbott Lowers Outlook But Headwinds Are Temporary

 

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
• By 

An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.

Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
• By 

The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.