The FDA recently gave 510(k) clearance to a U.S. biotech company looking to begin marketing a new system for cardiac signal acquisition and display. The new system will assist electrophysiologists as they seek to make decisions about cardiac patients in need of treatment for arrhythmia.
Rock West Solutions, a California company that works with the biotech industry to improve medical devices and signal processing, explains that 501(k) approval is the final hurdle to marketing a new medical device. The approval signifies that a device is safe and effective while also being substantially equivalent to a similar device already being marketed and not subject to premarket approval.
What Substantial Equivalency Means
Demonstrating substantial equivalence doesn’t mean this new cardiac signal system is identical to other systems on the market. It simply means that the system does, at the very least, what other available systems already do. It can, and does, do more.
Similar devices on the market already acquire, amplify, process, and filter cardiac signals. The newly approved device does all of that and more. According to an August 18 (2018) news report from Compelo, the device improves on the results of competing devices by minimizing “noise and artifacts” and capturing “high fidelity cardiac signals.”
The Role of Signal Processing
Rock West explains that the new device is all about advanced digital signal processing. Medical devices measure all sorts of signals coming from the human body. This includes standard EEP machines used by cardiologists and electrophysiologists. But those signals are not necessarily as useful as they could be in their raw form.
Digital signal processing takes cardiac signals and does several things to produce useful data. First, it filters out noise – a.k.a., unwanted information that doesn’t pertain to what is being studied. Next, it amplifies the information that remains after filtering.
Producing useful information is just the start of delivering better results. The next stage is analyzing the information to learn what doctors want to know. In order for data analysis to be spot on though, processed signals need to be spot on as well. That’s where this new cardiac system comes into play. It improves both signal acquisition and processing to give doctors and electrophysiologists a clearer picture of what’s going on.
Increased Diagnostic Value
Compelo reports that the new system has already been shown effective in no fewer than 12 preclinical studies conducted at the Mayo Clinic, UCLA Medical Center, and Mount Sinai Hospital. Now that the system is ready for market, the company behind it insists that their technology will increase the diagnostic value of routine EP procedures.
Under FDA rules, the device must only be used under the supervision of licensed professionals. Used properly, it should improve both accuracy and efficiency. The data produced will be utilized in the lab for study purposes as well as in clinical settings where direct patient treatment is being provided.
Understanding the Body More
News of the FDA approving a new cardiac signal system probably doesn’t mean much to the average consumer. But it means everything to companies like Rock West Solutions. It means that technology is giving us a greater understanding of the human body and how it’s supposed to operate. With that understanding comes the potential for more research, better treatments, and improved patient outcomes.
At the heart of it all is the modern era of digital signal processing. By applying the latest technologies, scientists have been able to produce a better cardiac signal system that will give doctors a clearer understanding of what is happening with their patients. That’s good news for all of us.