Cydar secures FDA 510(k) clearance for 3D surgical guidance software

21 July 2016 (Last Updated July 21st, 2016 18:30)

UK-based Cydar Medical has secured the US Food and Drug Administration (FDA) 510(k) clearance for its EV surgical guidance software to be used for x-ray guided vascular surgery.

UK-based Cydar Medical has secured the US Food and Drug Administration (FDA) 510(k) clearance for its EV surgical guidance software to be used for x-ray guided vascular surgery.

Cydar EV will provide fully-automatic computer vision which will monitor patients undergoing an x-ray guided surgery, thereby enabling an integration of diagnostic scan, planning information and real-time imaging with precision.

It is compatible with any existing X-ray system, while providing the surgeon with a detailed 3D enhanced reality view of anatomy.

"We are excited to show that this approach can have real clinical impact."

Clinical studies have showed that this enhanced 3D information is instrumental in minimising X-ray exposure to staff and patients as well as reducing the usage of kidney-toxic contrast agents and shortened procedure times.

Cydar co-founder and CEO Tom Carrell 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 is 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 are 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."

CYdar EV is currently being used in two London hospitals which are the Royal Free and Guy's & St Thomas' NHS Trust.