FDA Approved AI-Based Image Analysis Tool for Intravascular OCT

February 22, 2022

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Dyad Medical announced that its automated image analysis tool for visualizing and quantifying intravascular OCT images has received FDA clearance.

Intravascular OCT is used to perform preclinical and clinical assessments to optimize stent design, but manual image interpretation and analysis is time-consuming, so an automated solution (Libby IAAA) using the artificial intelligence has been developed, the company said in a press release.


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“Various studies link the use of imaging tests to improved patient outcomes. However, the subsequent demand for medical image interpretation skills appears to be a challenge,” Ronny Shalev, PhD, co-founder and CEO of Dyad Medical, told Healio. “This creates a huge increase in clinician workload, leading to dangerously large backlogs and practitioner burnout. We are reaching a breaking point where minor improvements to current standards of manual analysis succumb to time pressures. In addition, other challenges are becoming increasingly common, including disagreements among experts, misdiagnosis rate, and shortage of professionals.

Because of these issues, intravascular imaging decisions are often based on incomplete or insufficient data, he said.

“Even for trained experts, today’s fast-paced clinical workflow precludes full assessment of intravascular images during the procedure, a process that can require hours of manual labor. Currently, there is no clinical software tool that can perform comprehensive, automated analysis of intravascular images,” Shalev told Healio. “Using Libby, the end user will have the ability to perform comprehensive scans without compromising quality, potentially improving patient outcomes and satisfaction.”

Reference:

https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210931.pdf.

For more information:

Ronny Shalev, PhD, can be contacted at [email protected]

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