The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.
The healthcare ecosystem needs to be more proactive in managing cybersecurity risks.
A guide to the steps companies can take to evaluate their device developer’s HFE process.
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
There is still much to learn about the benefits and potential of robotic surgery.
When developing longer-lasting adhesives, designers must consider skin dynamics and the overall function of the product very early in the design phase.
The agency wants to modernize its regulatory processes and make them more efficient.
European scientists have developed a handheld scanner that works similar to a supermarket scanner for early detection of cardiovascular disease.
The Inspiris Resilia valve is intended for aortic valve replacement.