Lightpoint Medical Earns CE Mark for Robotic Gamma Probe

January 20, 2021

Lightpoint Medical, a medical device company developing miniaturized surgical tools for advanced intra-operative cancer detection, has received CE Mark approval for SENSEI, a robotic gamma probe that will be commercially available to European hospital systems.

The SENSEI has been designed for intra-operative detection of sentinel lymph nodes as well as cancer metastasis through the lymphatic system, the company said. The goal will be to provide more precise, targeted cancer surgery and can be applied across several major cancer types, including lung, colorectal, stomach, gynecological, and prostate cancer.

“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,” said Dr. David Turch, CEO of Lightpoint Medical. “Currently, surgeons have no way to precisely detect cancer intra-operatively. As a result, millions of patients suffer every year as cancer is frequently left behind or healthy, functional tissue is needlessly removed.”

Dr. Jim Adshead, a robotic surgeon at the Lister Hospital, East and North Herts NHS Trust, said he was excited for the approval and is 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.”

The SENSEI locates SPECT radioligands such as 99mTc-nanocolloid for sentinel lymph node detection or cancer-targeted drugs for cancer metastasis detection such as 99mTc-PSMA (Prostate-Specific Membrane Antigen) in prostate cancer surgery, the company said. Successfully registered with the U.S. FDA in September 2020, the CE Mark approval now allows surgeons in Europe to use the system.