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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.

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Left Hand Robotics acquired by Toro

Left Hand Robotics

The RT-1000 from Left Hand Robotics can mow large fields and plow snow. | Credit: Left Hand Robotics

Left Hand Robotics, a Longmont, Colo.-based developer of autonomous lawn mowing and snow plowing robots, was acquired by Toro. Terms of the transaction were not disclosed.

Founded in 2016, Left Hand Robotics initially developed and sold the RT-1000 multi-purpose robot. It comes with multiple attachments that can be switched out depending on the task at hand. The robot follows a pre-programmed path that users can create and edit themselves as needed.

The RT-1000 operates autonomously using triple-band GNSS RTK technology, as well as LiDAR, radar and six cameras for real-time object detection and avoidance. The RT-1000 uses a NVIDIA Jetson TX2 to process all the data the robot captures. The RT-1000 mows up to two acres and clears two miles of sidewalk per hour and can mow 20 acres on one tank of gas.

Then in March 2020, the company launched Bolt, an autonomous navigation system that is retrofitted onto manually-driven machines to turn them into autonomous robots. In addition to autonomous navigation, Bolt offers a sensor package, connected power equipment and controls, a cloud-based dashboard and job planning, reporting and analysis of the robots.

“Almost five years ago, we set out to address the physically demanding and not-too-fun problem of clearing snow by building a robot to do that work,” Left Hand Robotics wrote on its Facebook page to announce the acquisition. “It’s been quite a journey since, learning a lot about how difficult a problem that really was, but successfully tackling it – and then mowing – nonetheless. It was all due to being able to build a talented team that overcame the challenges – both engineering and then COVID. Definitely not an easy time to be building any company, much less one like ours. But all’s well that ends well and we look forward to continuing the journey in our new home. Thanks to all our friends, family, investors, dealers and certainly our customers for your trust and support.”

Left Hand Robotics raised a $3.6 million Series A round of financing in August 2019. According to Crunchbase, the company has raised a total of $8.9 million over three funding rounds.

Toro said the acquisition will supports its development of next-generation technologies, including alternative power, smart connected, and autonomous products. Bloomington, Minn.-based Toro is a leading provider of outdoor equipment for turf and landscape maintenance, snow and ice management, underground utility construction, rental and specialty construction, and irrigation and outdoor lighting solutions. It had sales of $3.4 billion in fiscal 2020 and has a presence in 125-plus countries.

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