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Asensus Senhance surgical robotic receives FDA 510(ok) clearance


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Asensus Senhance surgical robotic receives FDA 510(ok) clearance

Asensus says that by digitizing the interface between surgeon and affected person, performance-guided surgical procedure (PGS) with Senhance will help ship extra constant outcomes. | Credit score: Asensus Surgical

Asensus Surgical Inc. this week mentioned the U.S. Meals and Drug Administration has granted 510(ok) clearance for the Senhance Surgical System. The surgical robotic is designed to deal with grownup and pediatric urology sufferers.

“This FDA clearance marks one other milestone for Asensus Surgical and represents an extra indication enlargement within the U.S. market,” said Anthony Fernando, president and CEO of Asensus. “The Senhance system’s precision and superior digital capabilities make it uniquely fitted to urological procedures, providing surgeons the good thing about digital instruments and smaller instrumentation.”

Greater than 185,000 urological surgical procedures are carried out annually within the U.S. Whereas the Senhance system has been efficiently used for urology procedures exterior the U.S. for a number of years, this expanded indication will enable this method to assist an extra U.S. inhabitants, mentioned the Analysis Triangle Park, N.C.-based firm.

Rocky Mountain Hospital for Kids to deploy Senhance

Asensus Surgical not too long ago introduced that The Rocky Mountain Hospital for Kids in Denver, a part of HCA Healthcare’s HealthONE community, has signed an settlement to make the most of the Senhance Surgical System. The Rocky Mountain Hospital has about 200 subspecialty physicians in neonatology, pediatric intensive care, pediatric oncology, and pediatric cardiology who present 24/7 pediatric care.

“We’re thrilled to announce the primary devoted pediatric hospital placement of a Senhance System within the U.S.,” Fernando mentioned. “This displays our shared dedication to innovation and patient-centered care, with the last word purpose of bettering the lives of youngsters present process surgical procedures.”


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Robots promise to remodel ORs, says Asensus

With its intra-operative Augmented Intelligence techniques licensed for working rooms worldwide, Asensus Surgical claimed that it is remodeling surgical procedure. The firm asserted that it’s making surgical procedure extra accessible and predictable whereas bettering outcomes.

Robotic-assisted surgical procedure augments clinicians’ abilities and allows these surgeons to constantly ship high-quality outcomes to sufferers, even when performing rare procedures, mentioned Asensus. Via using AI as a co-pilot, surgeons of various abilities can all have constructive outcomes.

As Transenterix Inc., Asensus designed Senhance for basic laparoscopic and laparoscopic gynecological procedures. The corporate gained FDA clearance for the system in 2017. Since then, it has secured expanded indications, offers with Google and Nvidia, and hospital placements around the globe

In June, Asensus agreed to be acquired by Karl Storz, rising the endoscopy firm’s portfolio and market presence inside the surgical robotics house. The corporate has additionally designed the Luna system, for which it expects to get FDA approval subsequent yr.

Senhance designed for pediatrics

“The Senhance System, uniquely fitted to pediatrics, is a helpful addition to our surgical toolkit,” mentioned Dr. Steve S. Rothenberg at The Rocky Mountain Hospital for Kids. “The system’s superior options maintain promise for bettering outcomes in pediatric and adolescent surgical procedure, aligning with our dedication to protect the advantages of minimally invasive surgical procedure whereas pursuing innovation and excellence in affected person care.”

Dr Rothenberg mentioned robotic surgical instruments within the following video from Asensus:

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