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Home » FDA clears U.K. start-up Cydar’s surgical guidance software

FDA clears U.K. start-up Cydar’s surgical guidance software

July 26, 2016 By Fink Densford

CydarThe FDA last week cleared U.K.-based imaging and guidance developer Cydar EV‘s surgical guidance software designed for X-ray guided vascular surgery.

The Cydar EV guidance system uses fully-automatic computer vision to track patients during X-ray guided surgery, allowing the combination of diagnostic scanning, planning information and real-time imaging, the company said.

“This FDA clearance is a crucial step in delivering our technology globally and is a great endorsement of the accuracy and robustness of our computer vision software – it’s further proof that our science works. There has been a lot of talk recently about the potential of cloud computing and artificial intelligence with health data and improving patient outcomes. We are excited to show that this approach can have real clinical impact. We’re looking forward to extending its applications into other fields such as cancer and orthopaedics and using machine learning to provide new insights and help refine surgical planning,” CEO Tom Carrell said in a press release.

Cydar EV’s system is designed to work with any X-ray system, the company said, and provides the operating surgeon with a detailed 3D augmented reality view of the patient’s anatomy.

The company said that early clinical studies indicated that the extra 3D information from the system is associated with reductions in X-ray exposure to staffs and patients, as well as lower use of contrast agents and shortened procedure times.

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, Software / IT Tagged With: Cydar EV

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