Introduction
Asensus Surgical Inc. has recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Senhance Surgical System, its intra-operative Augmented Intelligence system, designed for general laparoscopic and laparoscopic gynecological procedures. This clearance marks another significant milestone in Asensus’ mission to transform the surgery landscape.
Asensus Senhance Surgical Robot Receives FDA 510(k) Clearance
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Asensus says that by digitizing the interface between surgeon and patient, performance-guided surgery (PGS) with Senhance can help deliver more consistent outcomes. | Credit: Asensus Surgical
Asensus Surgical Inc. this week said the U.S. Food and Drug Administration has granted 510(k) clearance for the Senhance Surgical System. The surgical robot is designed to treat adult and pediatric urology patients.
“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” stated Anthony Fernando, president and CEO of Asensus. “The Senhance system’s precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation.”
Rocky Mountain Hospital for Children to deploy Senhance
Asensus Surgical recently announced that The Rocky Mountain Hospital for Children in Denver, part of HCA Healthcare’s HealthONE network, has signed an agreement to utilize the Senhance Surgical System. The Rocky Mountain Hospital has about 200 subspecialty physicians in neonatology, pediatric intensive care, pediatric oncology, and pediatric cardiology who provide 24/7 pediatric care.
“We are thrilled to announce the first dedicated pediatric hospital placement of a Senhance System in the U.S.,” Fernando said. “This reflects our shared commitment to innovation and patient-centered care, with the ultimate goal of improving the lives of children undergoing surgical procedures.”
Robots promise to transform ORs, says Asensus
With its intra-operative Augmented Intelligence systems certified for operating rooms worldwide, Asensus Surgical claimed that it is transforming surgery. The company asserted that it is making surgery more accessible and predictable while improving outcomes.
Robot-assisted surgery augments clinicians’ skills and enables these surgeons to consistently deliver high-quality results to patients, even when performing infrequent procedures, said Asensus. Through the use of AI as a co-pilot, surgeons of varying skills can all have positive outcomes.
As Transenterix Inc., Asensus designed Senhance for general laparoscopic and laparoscopic gynecological procedures. The company won FDA clearance for the system in 2017. Since then, it has secured expanded indications, deals with Google and Nvidia, and hospital placements around the world.
In June, Asensus agreed to be acquired by Karl Storz, growing the endoscopy company’s portfolio and market presence within the surgical robotics space. The company has also designed the Luna system, for which it expects to get FDA approval next year.
Senhance designed for pediatrics
“The Senhance System, uniquely suited for pediatrics, is a valuable addition to our surgical toolkit,” said Dr. Steve S. Rothenberg at The Rocky Mountain Hospital for Children. “The system’s advanced features hold promise for improving outcomes in pediatric and adolescent surgery, aligning with our commitment to preserve the benefits of minimally invasive surgery while pursuing innovation and excellence in patient care.”
Dr. Rothenberg discussed robotic surgical tools in the following video from Asensus:
This milestone marks a significant achievement for Asensus Surgical, as the Senhance System receives FDA 510(k) clearance for treating adult and pediatric urology patients. The system’s advanced digital capabilities and precision ensure improved outcomes, making surgery more accessible and predictable.
Frequently Asked Questions
QUESTION 1: What is the Senhance System?
The Senhance System is an intra-operative Augmented Intelligence system designed for general laparoscopic and laparoscopic gynecological procedures.
QUESTION 2: Who has granted clearance for the Senhance System?
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Senhance Surgical System.
QUESTION 3: What is the primary use for the Senhance System?
The primary use for the Senhance System is to treat adult and pediatric urology patients.
QUESTION 4: What are the advanced features of the Senhance System?
The Senhance System boasts advanced digital capabilities, precision, and innovative features that enable improved outcomes for patients.
QUESTION 5: What is the potential impact of this clearance on the healthcare industry?
This clearance has the potential to revolutionize the healthcare industry by bringing innovative and effective surgical robotic technology to patients in need.
