In August, the short-selling investment firm Muddy Waters and cybersecurity firm MedSec Holdings claimed St. Jude’s pacemakers and defibrillators contained cybersecurity flaws, which caused the St. Paul, Minn.-based device maker’s stock to fall.On Wednesday, St. Jude filed a lawsuit against the companies, alleging they intentionally released false information to manipulate St Jude’s stock.
“Regardless of the way a vulnerability comes to our attention, we take those allegations very, very seriously,” FDA official Suzanne Schwartz, MD, told Reuters. “We are putting all of our focus on making sure that we have an understanding of what these allegations are and do a thorough investigation of the claims.”
Dr. Schwartz said that Muddy Waters and MedSec’s method of pointing out the alleged flaws violated advice the FDA issued in a January draft guidance that encouraged researchers to work directly with manufacturers to address suspected security issues.
More articles on supply chain:
Pfizer CEO: Clinton’s plan to lower drug costs is bad for consumers
4 drug companies on Fortune’s ‘Change the World’ list
Device companies struggle to meet UDI requirements: 4 things to know
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
