"The future of surgery is not about blood and guts; the future of surgery is about bits and bytes.”
/Dr. Richard Satava/

Monday, August 15, 2011

ROBODOC advances--the story of an FDA approval

I was happy to cover the FDA approval of the ROBODOC almost 3 years ago. Since then, a lot of effort has been put into the field. It's time to look back on this historical event.
The clearance procedure of the system was quite long and full of edifying stories. It was the first system that tried to get through the clearance procedure, and it was forced into the PMA category, since no equivalent technology existed.
  • October 1992, the FDA granted an IDE approval to conduct limited clinical trials (at Sutter General Hospital in Sacramento).
  • November 7., the world’s first robotic joint replacement surgery was performed .
  • A biomedical engineer for the FDA outlined comprehensive investigative testing designed to test the safety of the robotic control software.
  • In 1993, ISS began the PMA clearance procedure. The ROBODOC software and hardware had to comply with robust motion control restrictions to prevent accidental tissue and bone damage.
  • In 1996, it received the European CE mark and approval for Total Hip Arthroplasty (THA) procedures.
  • In 2002, the FDA re-assigned the ROBODOC system to its 510(k) path. Unfortunately, by this time, ISS no longer had sufficient capital to support the procedure.
  • By 2004, the significant R&D cost related to further testing and re-submission caused ISS to cease operations.
  • In November 2007, all assets and IP were transferred Curexo Technology Corporation, and $12M were invested to continue the business.
  • The fresh money allowed to finish trials, and to complete the robot’s commercialization via FDA 510(k).
  • In August 2008, the system finally received a 510(k) clearance from FDA. 
Throughout these years, all the FDA-cleared surgical robots (e.g., da Vinci, NeuroMate, CyberKnife, ROBODOC, MAKO Arm, SpineAssist) went down the 510(k) procedure, proven to be substantially equivalent to existing technologies. FDA’s emphasis has gradually shifted from the robotic technology itself to approving the results of the use of the robotic systems. It is now believed that the equivalence stands between the already-approved surgical techniques and the results attained through robotic interventions. 

3 comments:

Lee said...

Do you mean "cease operations" in "By 2004, the significant R&D cost related to further testing and re-submission caused ISS to seize operations."

T. said...

Hmmm. Indeed, thanks!

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