AI-based image analysis tool for intravascular OCT cleared by FDA
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Dyad Medical announced its automated image analysis tool to view and quantify intravascular OCT images has been granted clearance by the FDA.
Intravascular OCT is used to conduct preclinical and clinical evaluations to optimize stent design, but manual interpretation and analysis of the images is time-consuming, so an automated solution (Libby IAAA) using artificial intelligence was developed, the company stated in a press release.
“Various studies link the use of imaging examinations to improved patient outcomes. However, the subsequent demand for medical image interpretation skills emerges as a challenge,” Ronny Shalev, PhD, co-founder and CEO of Dyad Medical, told Healio. “It creates an enormous increase in workload for clinicians, leading to dangerously large backlogs and burnout of practitioners. We are hitting a breaking point where minor improvements to the current standards of manual analysis succumb to time pressures. Furthermore, other challenges are becoming more prevalent, including disagreement among experts, diagnostic error rate and a shortage of professionals.”
Because of those issues, intravascular imaging decisions are often based on incomplete or insufficient data, he said.
“Even for trained experts, the current fast-paced clinical workflow precludes comprehensive evaluation of intravascular images during the procedure, a process that can require hours of manual labor to complete. At present there are no existing clinical software tools that can perform comprehensive automated intravascular image analysis,” Shalev told Healio. “Using Libby, the end user will have the ability to perform comprehensive analyses without compromising on quality, potentially improving outcome and patient satisfaction.”
Reference:
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210931.pdf.
For more information:
Ronny Shalev, PhD, can be reached at info@dyadmed.com.
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