FDA grants clearance for Cydar surgical guidance software
July 26, 2016
The US Food & Drug and Administration (FDA) has granted 510(k) clearance for the UK-based start-up Cydar's EV surgical guidance software, used in x-ray guided vascular surgery.
Cydar claims to be the first company in the world to use 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 to combine diagnostic scan, planning information and real-time imaging with millimetre precision.
Capable of working with any existing x-ray system, it 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," said Cydar co-founder and CEO Tom Carrell. “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."
Cydar EV is used in two prominent London hospitals – the Royal Free and Guy's & St Thomas' NHS Trust.
Founded in 2012, Cydar is a private company that was spun out of Kings College London and Guy's & St Thomas' NHS Trust. It has successfully completed two clinical studies and now gained regulatory approval both in the USA and Europe (CE mark).
Carrell and co-founder Graeme Penney – an imaging scientist – came up with the idea after becoming frustrated with the poor quality of the imaging technology used in the operating theatre. The name Cydar stands for “Can you do another registration?”, a question Carrell routinely asked Penney while working with an early prototype in the operating theatre.