A recent webinar highlighted the need for manufacturers to monitor, manage, and address software vulnerabilities under FDA cybersecurity policy. Important elements include a thorough software bill of materials, coordinated vulnerability disclosure, and maintaining system security.
Developers of devices that include software need to be aware of the US Food and Drug Administration’s “cyber device” expectations, two former FDA reviewers said during a late February webinar.
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Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
An interactive look at medtech and diagnostics deals made during June 2025. Data courtesy of Biomedtracker.
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
