Asensus Surgical Receives 510(k) Clearance from FDA

Medical device company, Asensus Surgical, Inc., (NYSE American: ASXC), has received 510(k) clearance from the FDA for an expanded indication to treat pediatric patients with the Senhance® System.

Highlights

  •  Asensus’ Senhance System combines 3mm instrumentation, 5mm camera scope, haptic feedback, and advanced clinical intelligence provided by the Intelligent Surgical Unit™ to bring the benefits of surgical robotics to pediatric patients.
  • The Senhance System uses the least invasive instruments and scopes possible, while maintaining a high level of precision and stability. This is important due to the small size of pediatric patients.
  • The company’s Senhance System is already approved for pediatric patients in the EU and Japan.
  • Asensus looks forward to bringing the benefits of surgical robotic technology to the underserved pediatric patient population in the United States.

Asensus says it has seen strong early clinical utilization in Europe, with surgeons having successfully performed pediatric general, upper GI, colorectal and urologic procedures using the Senhance System.

Disclaimer

This communication was produced by Prism MarketView, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is an integrated investor relations, communications and strategic advisory firm. The information contained on this is ‘Paid Advertising’ for purposes of Section 17(b) of the Securities Act of 1933, as amended (together with the rules and regulations there under, the “Securities Act”). “PCG” and its affiliates are compensated by respective clients for publicizing information relating to its client’s securities. For more information in terms of compensation received for services provided by PCG, see the pertinent advertising materials relating to the respective client. By accessing this Site and any pages thereof, you agree to be bound by the Terms of Use and Privacy Policy…

Read Full Disclaimer

Share This Article

 

About the Author

Asensus Surgical Receives 510(k) Clearance from FDA

Editor Prism MarketView