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.


  •  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.


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Asensus Surgical Receives 510(k) Clearance from FDA

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