We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....
The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to...
How Do Laboratory Developed Tests Impact Your Business? The Office of Public Health Strategy and Analysis recently issued a report that reviewed 20 products that relied on Laboratory Developed Tests (LDTs) to determine whether a lack of oversight may have caused actual harm to patients or not. Once, LDTs were relatively simple tests that may not...
Part 1 – Medical Device Software, the FDA and the US Congress Preface: In any given 2-week period, an average of 15% to 20% of the applications on my smartphone have new versions to fix software bugs. Others I speak with experience similar statistics. And, that doesn’t include how often my smartphone software crashes while...