The FDA's recall of 465,000 Abbott Laboratories pacemakers earlier this week alerted medical-device makers that they increasingly need to be prepared to issue security updates and take cybersecurity issues more seriously.
St. Jude Medical, which is now part of Abbott Laboratories, failed to appropriately correct issues found in some of its cardiovascular devices, according to the U.S. Food and Drug Administration.
The businesses in question produce vascular closure devices, or VCDs, used to close holes in arteries following the insertion of catheters; and steerable sheaths, used to guide catheters for treating heart arrhythmias.
The CMS is proposing Medicare coverage for leadless pacemakers, but only those used in federally approved clinical studies.
Medical-device manufacturer St. Jude Medical has announced it will form an advisory board to address cybersecurity concerns following claims from short-sellers that its pacemakers and other devices are vulnerable to hacks.
The recent fracas over the Muddy Waters report about St. Jude Medical's devices raises a number of questions, such as: What are appropriate ways to disclose a vulnerability that may have clinical implications?
Medical-device manufacturer St. Jude Medical once again denied allegations Tuesday that its pacemakers and other devices had security weaknesses, while independent researchers found flaws in a critical report by the short-selling investment firm Muddy Waters and cybersecurity company MedSec.
Physicians are increasingly selling their practices to larger groups to gain access to the capital and expertise needed to survive under value-based reimbursement.
Institutional investors are pushing for a range of reforms at publicly traded healthcare firms. High on the agenda is easier access to proxy ballots for an alternative slate of board directors.
Community Health Systems has completed its spinoff of 38 hospitals into a separate, independent company, Quorum Health Corp. Quorum begins trading to the general public on Monday under the symbol QHC.
Abbott Laboratories will spend $19.3 billion to buy St. Jude Medical in a cash-stock deal that aims to strengthen the medical-device maker's share of the market for cardiovascular care.