Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
“We are honored to have Dr. Lace, who is widely recognized as one of the industry’s most trusted reimbursement experts, leading our new division. He will also support all our services as our CMO.”
Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring (RPM) and Hospital at Home programs. The software platform and algorithms tasked with integrating and evaluating data must identify the data that matters, when it matters.
A review of the top six reasons there has been a dramatic increase in the adoption of remote care among seniors.
The short answer is yes, but doing your homework in advance is now more important than ever.