Echocardiogram app receives FDA clearance
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Dyad Medical announced its application providing data-driven analysis of echocardiogram images has received 510(k) clearance from the FDA.
The app (Echo:Prio) provides automated analysis of echocardiogram images that may be more reliable than subjective visual interpretations, according to a press release from the company.
“Echocardiograms are the most-used imaging modality due to its low cost, portability, and widespread availability. However, the challenges of echocardiograms include its suboptimal acoustic windows, operator dependence and use of geometric assumptions,” Ronny Shalev, PhD, co-founder and CEO of Dyad Medical, told Healio. “Due to these challenges, interpretation of echocardiographic images typically requires extensive training. Yet, even among expert trained practitioners, the rate of disagreement on findings ranges between 20% and 40%, leading to potential suboptimal treatment decisions. Dyad Medical’s Echo:Prio is reliable and high-quality software built to overcome these challenges. Since our software learns from the collective insight of multiple experts, with the ability to improve over time, its level of performance ensures that the end user will always have an extremely reliable second opinion. This supports their treatment decision-making.”
The app is used with Dyad’s cloud-based Libby platform, so users can access it from any device, according to the release.
“More people die as a result of cardiovascular disease than all types of cancer, diabetes and accidents combined,” Shalev told Healio. “For providers treating CVDs, our technology will play a role in increasing their throughput, functioning as an immediately available second opinion. Our solution will guide a cardiologist in the interpretation of a case. It will expand physicians' view, so they have greater confidence in their diagnosis, leading to greater patient satisfaction and retention.”
For more information:
Ronny Shalev, PhD, can be reached at info@dyadmed.com.
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