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First robot-assisted system for transvaginal hysterectomy approved by FDA

The U.S. Food and Drug Administration (FDA) authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. According to the FDA, Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy.

Using minimally invasive surgical instruments inserted through the vagina and a video camera inserted laparoscopically through a small incision on the abdomen, the Hominis surgical system is designed to remove the uterus. The transvaginal approach requires fewer incisions on the abdomen compared to the traditional laparoscopic hysterectomy, the FDA said.

Surgeons in the operating room control instruments during the procedure through the Hominis system console, for which the FDA will require Memic to develop and provide a training program for surgeons and operating room staff to complete before operating the device.

Hominis

Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. | Credit: Memic Innovative Surgery

The FDA evaluated the safety and effectiveness of the system in a trial of 30 patients undergoing transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions. Patients were spaced out age-wise, ranging from 37 to 79 years old, while 63% of patients had different comorbidities.

All 30 of the procedures done with Hominis were successfully completed with no conversions to an open laparoscopic surgical approach or another form of such an approach. Minor blood loss, urinary tract infection and the delayed healing of the closure made at the top of the vagina were observed as adverse events during the procedures.

“We are providing physicians and patients another minimally-invasive gynecologic surgical option for non-cancerous conditions,” FDA director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health Dr. Binita Ashar said. “The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures.”

Editor’s Note: This article first appeared on our sister website MassDevice.

The post First robot-assisted system for transvaginal hysterectomy approved by FDA appeared first on The Robot Report.

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Intelligent Surgical Unit machine vision guidance from TransEnterix gets FDA approval

TransEnterix Surgical Inc. today announced that the U.S. Food and Drug Administration has granted it 510(k) clearance to add the Intelligent Surgical Unit, a machine vision enhancement, to its Senhance robot-assisted surgical system.

Senhance is intended to assist in the accurate control of laparoscopic instruments for procedures including gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. It is approved for use in the U.S., the EU, Japan, and select other countries.

The Intelligent Surgical Unit uses artificial intelligence to enable the system’s camera to automatically move for a surgeon during a procedure. It can respond to commands and recognize certain objects and locations in the surgical field. Research Triangle Park, N.C.-based TransEnterix secured the clearance only two months after filing.

“We are pleased to have received this important clearance earlier than expected,” stated Anthony Fernando, CEO of TransEnterix. “Machine vision is the next major advance in digital surgery.”

Intelligent Surgical Unit optimizes vision-based control

“Our system is designed to significantly advance the sensing capabilities of computer-assisted surgery,” said Fernando. “With this hardware and software system, the Senhance system will gather and interpret visual information from the surgical field.”

“The capabilities now cleared will be focused on optimizing visualization and camera control in ways never before offered in robotic or digital surgery,” he added. “These initial capabilities represent the first step in our journey to bring the benefits of augmented intelligence and machine vision to surgery.”

Eventually, the system could have an overwatch feature in which the system would use scene cognition and image analytics to provide a surgeon suggestions based on accumulated laparaoscopic experience around Senhance.

TransEnterix submits Intelligent Surgical Unit machine vision system to the FDA

The Intelligent Surgical Unit is designed to help doctors visualize the surgical field with the Senhance surgical system. Source: TransEnterix

“This is the beginning of a new era in digital surgery,” said Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center in New Jersey and a participant in the design and usability studies for the 510(k) submissio. “Surgery is the skilled real-time application of vision, experience, precise motion, and decision making. The opportunity to use a computer to see aspects of the field and guide surgery is enormous. I am eager to utilize machine vision to better control the camera seamlessly during my surgeries.”

The Intelligent Surgical Unit is compatible with both the global installed base of Senhance surgical systems and with third-party vision systems that they support.

Last year, TransEnterix sold only three Senhance systems, which which boast haptic feedback, surgeon camera control via eye sensing and improved ergonomics.

Last month, TransEnterix said it planned to raise $25 million in a stock purchasing agreement. In addition to its push into AI with the Intelligent Surgical Unit, the company been experimenting with robot leasing agreements to encourage adoption of its surgical robotics.

Editor’s note: This article first appeared on MassDevice, a sibling site to The Robot Report focusing on medical devices.

The post Intelligent Surgical Unit machine vision guidance from TransEnterix gets FDA approval appeared first on The Robot Report.