Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities
Additional Intelligent Surgical Unit™ (ISU™) features will further extend augmented intelligence leadership in surgery
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The Senhance Surgical System pictured with the latest ISU model that includes expanded augmented intelligence features such as 3D measurement and enhanced camera control. (Graphic: Business Wire)
“We are thrilled to have received FDA clearance for our next generation of augmented intelligence features on the ISU,” said
The current features of the ISU enable machine vision-driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical field, and allow a surgeon to change the visualized field of view using the movement of their instruments. The newest ISU features expand upon these capabilities and introduce more advanced features including: 3D measurement, digital tagging, image enhancement, and enhanced camera control based on real-time data from anatomical structures while performing surgery. This will be the first time any of these features will be clinically available in soft-tissue abdominal surgery.
“This is a new era in digital surgery,” said Dr.
“Utilizing real-time 3D measurement tools would be valuable to evaluate margins and estimate defect sizing,” said Dr.
The 3D measurement feature enables the surgeon to use their instruments to designate points on the tissue floor to determine both straight-line distances as well as true topographic distances over the folds and recesses of the abdominal cavity. In traditional minimally invasive surgery, such measurements are estimated or require the use of a sterile measuring tape inside the abdominal cavity. Now 3D measurement allows for accurate readings to millimeter-level accuracy that can assist in various surgical tasks, such as the sizing of hernia mesh or the planning of a staple line. These measurement capabilities represent the first time surgeons have the ability to acquire accurate, real-time measurements without the need for additional tools.
Digital tagging introduces a new surgeon capability to make dynamic annotations on the live surgical camera view for real-time guidance and planning. Further, real-time underlying anatomy monitoring allows tags to persist through intraoperative camera movement. This has the potential to gain procedural efficiencies and delivers dynamic digital markers which preserves the tag locations while tissue is being manipulated.
Image enhancement dynamically adjusts the brightness and contrast of the surgical scene to provide a clear and consistent image, adaptively compensating for uneven illumination. Image enhancement facilitates high-quality video acquisition, which is a cornerstone of Performance-Guided Surgery. Because this feature is vision system agnostic, this benefit can be realized with all vision systems that are compatible with Senhance.
Enhanced camera control builds on existing methods of instrument-based camera control and directs camera positioning based on the tracked location of multiple instruments within the scene and allows for automatic adjustment of pan and zoom simultaneously to maintain visualization of the instruments. Always maintaining visualization of instruments in the field of view is a best practice for performing safe surgery.
The clearance of these expanded augmented intelligence features demonstrates the Company's commitment to delivering on the promise of Performance-Guided Surgery. The Company believes these additional features will provide meaningful support for surgeons across a range of specialties and procedures. Additionally, the foundational elements of these features will enable the Company to continue introducing novel augmented intelligence features in the future by leveraging the vast capabilities and potential of the ISU.
This press release includes statements relating to the Senhance Surgical System and the FDA 510(k) clearance for expansion of machine vision capabilities. 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 additional ISU features will further extend augmented intelligence leadership in surgery, whether the expanded ISU features, including 3D measurement, digital tagging, image enhancement and enhanced camera control based on real-time data from anatomical structures while performing surgery will be the first time to be clinically available in soft-tissue abdominal surgery and whether the ISU’s additional features will provide meaningful support for surgeons across a range of specialties and procedures. For a discussion of the risks and uncertainties associated with the Company’s business, please review our filings with the