CE Mark approval for ‘first’ robotic gamma probe

Lightpoint Medical, a medical device and equipment manufacturer based in the UK, has CE Mark approval for a robotic gamma probe called SENSEI®.

The company, which develops miniaturized surgical tools for ‘advanced intra-operative cancer detection’ says that the technology is the ‘first’ of its type to be ‘commercially available’ to European hospital systems.

SENSEI®’s CE Mark, which means the manufacturer takes responsibility for and intends to comply with the health, safety, and environmental protection standards for products sold within the European Economic Area, is for sentinel lymph node detection.

The technology is designed for ‘intra-operative detection of sentinel lymph nodes, as well as cancer metastasis, through the lymphatic system’.

It aims to enable more ‘precise, targeted’ cancer surgery for a number of ‘major cancer types’. This includes lung, colorectal, stomach, gynecological and prostate cancers.

Dr. David Tuch, CEO of Lightpoint Medical said: “Securing CE Mark for SENSEI® is an important milestone in our efforts to transform cancer surgery and underscores our commitment to meet surgeons’ needs for miniaturized cancer detection tools as robotic platform technologies grow to dominate surgical practice.”

Focusing on real-time cancer detection for ‘robot-assisted cancer surgery’, the robotic gamma probe will help surgeons detect cancer intra-operatively. It’s hoped this will reduce instances of cancer being left behind during procedures and of ‘functional tissue being needlessly removed’.

Robotic surgeon, Dr Jim Adshead, at the Lister Hospital, East and North Hertfordshire NHS Trust, UK added: “I am very excited about regulatory approval for SENSEI® and now eager to start using it in surgery.

“ I have been closely involved in the development of the technology since early usability testing and I’m extremely hopeful for its potential in advancing the treatment of prostate cancer”.

Lightpoint Medical has also registered SENSEI® with the FDA, the US’ Food and Drug Administration.