FDA investigates allegations against St. Jude Medical

The FDA is investigating allegations about cybersecurity flaws in St. Jude Medical’s cardiac devices, Reuters reports.

In late August, research firm Muddy Waters wrote a report warning investors that St. Jude’s pacemakers and defibrillators could be susceptible to hacking. Muddy Waters also said it had shorted St. Jude Medical’s stock.

St. Jude Medical then filed a lawsuit against Muddy Waters and MedSec Holdings, a cybersecurity research firm that warned Muddy Waters about the potential hacking issues.

“Regardless of the way a vulnerability comes to our attention, we take those allegations very, very seriously,” Suzanne Schwartz, MD, MBA, an FDA official, told Reuters in a telephone interview. “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.”

Read the full Reuters article below:

Tim Casey,

Executive Editor

Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.

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