Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System
With the combination of 3mm instrumentation, 5mm camera scope, haptic feedback, and advanced clinical intelligence provided by the Intelligent Surgical Unit™, the Company believes that the Senhance System is uniquely positioned to bring the benefits of surgical robotics to pediatric patients in a way that no other platform on the market can, by offering a unique and unmatched reduction in invasiveness on a robotic platform. We have seen strong early clinical utilization in
“We are excited to bring the benefits of surgical robotic technology to the underserved pediatric patient population in
The Senhance System is now indicated to perform pediatric procedures in the
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This press release includes statements relating to the Senhance Surgical System and the FDA’s 510(k) clearance for a pediatric indication for the Senhance Surgical System. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the Senhance Surgical System is uniquely positioned to bring the benefits of digital laparoscopy to pediatrics in a way that no other platform on the market can and whether the Senhance Surgical System is the perfect platform for use in pediatric patients. For a discussion of the risks and uncertainties associated with the Company’s business, please review our filings with the
Source: Asensus Surgical, Inc.