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. 2017 Feb;22(1):115-126.
doi: 10.1109/TMECH.2016.2618362. Epub 2016 Oct 20.

MR Safe Robot, FDA Clearance, Safety and Feasibility Prostate Biopsy Clinical Trial

Dan Stoianovici  1 , Chunwoo Kim  1 , Doru Petrisor  1 , Changhan Jun  1 , Sunghwan Lim  1 , Mark W Ball  1 , Ashley Ross  1 , Katarzyna J Macura  2 , Mohamad Allaf  1
Affiliations

MR Safe Robot, FDA Clearance, Safety and Feasibility Prostate Biopsy Clinical Trial

Dan Stoianovici et al. IEEE ASME Trans Mechatron. 2017 Feb.

Abstract

Compatibility of mechatronic devices with the MR environment has been a very challenging engineering task. After over a decade of developments, we report the successful translation to clinical trials of our MR Safe robot technology. MrBot is a 6-degree-of-freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive pre-clinical tests have been previously reported. Here, we present the latest technology developments, an overview of the regulatory protocols, and technically related results of the clinical trial. The FDA has approved the MrBot for the biopsy trial, which was successfully performed in 5 patients. With no trajectory corrections, and no unsuccessful attempts to target a site, the robot achieved an MRI based needle targeting accuracy of 2.55 mm. To the best of our knowledge, this is the first robot approved by the FDA for the MR environment. The results confirm that it is possible to perform safe and accurate robotic manipulation in the MRI scanner, and the development of MR Safe robots is no longer a daunting technical challenge.

Keywords: FDA; MR Safe; MRI compatible; Medical robotics; clinical trial; motor; pneumatic; prostate biopsy; robot.

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Conflict of interest statement

Disclosure Under a licensing agreement between Samsung and the Johns Hopkins University, Dr. Stoianovici has received income on an invention described in this article. This arrangement has been reviewed and approved by the JHU in accordance with its conflict of interest policies.

Figures

Figure 1
Figure 1
System schematic
Figure 2
Figure 2
a) The robot, b) Needle-driver, and c) Schematic of the needle-driver
Figure 3
Figure 3
Block diagram of the robot controller
Figure 4
Figure 4
Registration markers and image-to-model
Figure 5
Figure 5
Patient and robot in the MRI scanner
See this image and copyright information in PMC

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