FDA Clears Cydar EV 3D Surgical Guidance Software

The U.S. Food and Drug and Administration (FDA) has granted 510(k) clearance for the UK-based start-up Cydar’s revolutionary EV surgical guidance software, used in X-ray guided vascular surgery.
 
Cydar is the first company in the world using high performance cloud computing to provide surgical guidance in the operating room. At its core, fully-automatic computer vision tracks patients during X-ray guided surgery: enabling it combine diagnostic scan, planning information and real-time imaging with millimeter precision.
 
Capable of working with any existing X-ray system, Cydar EV provides the surgeon with a detailed 3D augmented reality view of anatomy. Early clinical studies have shown this enhanced 3D information is associated with large reductions in X-ray exposure to staff and patients, less use of kidney-toxic contrast agents and shortened procedure times.
 
“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,” said leading vascular surgeon, Cydar co-founder and CEO Tom Carrell.
 
“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.”
 
Cydar EV is used in two prominent London hospitals—the Royal Free and Guy’s & St Thomas’ NHS Trust.