aurishealth Archives - Medical Design Sourcing

FDA clears surgical robot from Noah Medical

The Galaxy System. [Image courtesy of Noah Medical]Noah Medical announced that it received FDA clearance for its Galaxy System for robotic-navigated bronchoscopy.

San Carlos, California-based Noah Medical designed Galaxy and its accessories to provide bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways.

The system features advanced imaging technologies that provide real-time location updates for potentially cancerous lesions. Noah said in a news release that it designed the technology to improve tool-in-lesion and diagnostic yield.

“While various technologies to diagnose lung cancer have been utilized over time, the diagnostic yield has remained relatively low,” said Jian Zhang, Noah Medical founder and CEO. “The Galaxy System is designed to close this gap in the market, giving clinicians a safe and easy-to-use platform to potentially improve diagnostic yield and produce better clinical…

J&J’s Ethicon completes first robot-assisted kidney stone removal with Monarch platform

The Monarch platform for robot-assisted urology procedures. [Image courtesy of Johnson & Johnson’s Ethicon]Ethicon, a Johnson & Johnson MedTech company, today announced the first robotic-assisted removal of kidney stones using the Monarch platform.

Auris Health, an Ethicon subsidiary, received FDA clearance for Monarch for endourological procedures in May 2022. The University of California, Irvine’s UCI Health used the Monarch platform for urology to complete the first procedure.

According to a news release, it’s the first successful robotically assisted, electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy procedure. Ethicon said its study involves a collaboration with co-investigator Dr. Mihir Desai from the University of Southern California.

“This clinical study is the first in the world to research and demonstrate the potential for improved navigation, access, clearance and control in mini-PCNL proce…

J&J’s Auris alleges former employees brought trade secrets to new company Noah Medical

Johnson & Johnson‘s Auris Health surgical robotics business filed litigation this week alleging misappropriation of trade secrets by Noah Medical.

In its complaint, Auris alleges “shameless, systematic and ongoing misappropriation of trade secrets” by Noah. It named former Auris employees Enrique Romo, Diana Cardona Ujueta and Kenneth Nip.

Among other things, J&J alleges that the three former employees collectively misappropriated at least 26,000 Auris, Verb and Cilag documents. Those documents comprise 81 gigabytes of data. According to the complaint, that data includes “significant trade secret material.”

Those documents feature source code, designs and test cases, according to the complaint. All have direct relevance to the individual defendants’ work at Noah, the company added.

“There is incontrovertible evidence that Noah used at least some of these stolen trade secrets: a Noah patent applicat…

FDA clears J&J’s Ethicon’s Monarch surgical robot for urology procedures

[Image from Auris Health’s website]Johnson & Johnson MedTech (NYSE:JNJ) company Ethicon announced today that its Monarch robotic surgery platform received FDA 510(k) clearance.

Ethicon’s Auris Health subsidiary received the FDA clearance for Monarch for endourological procedures, making it the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology.

The company said in a news release that it designed the Monarch robot-assisted surgical platform to enable urologists to reach and visualize areas within the kidney with precision and control. The system offers one platform for supporting both ureteroscopic and percutaneous nephrolithotomy (PCNL) procedures.

“Monarch reduces the complexity of gaining high-quality percutaneous access and aids stone clearance efficiency through simultaneous fragmentation and suctioning of stones with robotic assistance,” University of Southern Cali…

Encision signs supply agreement with J&J’s Auris Health

Encision today announced that it has entered a supply agreement with Johnson & Johnson (NYSE:JNJ) subsidiary Auris Health .

Through the agreement, Auris Health will buy certain Active Electrode Monitoring technology from Encision. Boulder, Colo.-based Encision will receive an upfront payment and a milestone payment upon certain milestones. The company will also receive revenues from proprietary product sales to Auris Health.

“We are happy to be teaming up with Auris to drive new levels of patient safety in robotic surgery. Encision’s Active Electrode Monitoring is a proprietary and differentiating technology that shields patients and practitioners from radiant energy injuries during standard and robotic laparoscopic surgeries. We welcome this next phase to our relationship,” Encision president and CEO Gregory Trudel said in a news release.

Encision’s Active Electrode Monitoring was designed to prevent dangerous stray electrosu…

J&J touts results of robotic bronchoscopy trial

Johnson & Johnson (NYSE:JNJ) subsidiary Auris Health is touting positive results from a study of its Monarch robotic bronchoscopy system.

Monarch, a first-of-its-kind robotic technology, was cleared by the FDA in March 2018 for diagnostic and therapeutic bronchoscopies. In May, Auris touted interim results from an independent feasibility study designed to assess the platform. In that study, in 82 procedures, researchers reported that although most of the lesions were less than 3cm in size the outer third of the lung, they were able to reach them in 94% of cases.

Auris published the results of its Benefit study to evaluate the safety and feasibility of the Monarch platform, led by Dr. Alexander Chen (St. Louis, Mo.) and Dr. Gerard Silvestri (Charleston, S.C.) in CHEST.

The trial enrolled 55 patients across five leading institutions: Washington University (St. Louis), Medical University of South Carolina, the Cleveland Clinic, Henry Ford Hospital and I…

J&J’s Ethicon wins FDA breakthrough nod for microwave ablation tech

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced that it received FDA breakthrough device designation for its microwave ablation technology.

The transbronchial microwave ablation technology, which is currently under development, utilizes robotic-assisted bronchoscopy. Johnson & Johnson’s acquisitions of NeuWave Medical and Auris Health allowed the company to bring the robotic surgical and microwave ablation technology together to develop the new breakthrough device, according to a news release.

Ethicon’s NeuWave microwave ablation system treats soft tissue lesions, having already performed more than 45,000 procedures to date. Meanwhile, the Monarch platform — the first robotic-assisted bronchoscopy system introduced in the U.S. — offers reach into the periphery of the lung with continuous real-time vision, precision and control.

“Through our commitment to transform patients’ lives, Johnson & Johnson is advancing innovativ…