Urology Week 2024, which closes out The Urology Foundation’s Urology Awareness Month, is a good time to highlight the innovations in this space.

This week (Sept. 23-29), is an initiative of the European Association of Urology that brings together national urological societies, urology practitioners, urology nurses, patients and their families, and politicians to create awareness of urological conditions among the general public.

(Our DeviceTalks West event in Santa Clara Oct. 16-17 is celebrating Urology Week — learn more and register at West.DeviceTalks.com and use code “INNOV8” for 25% off event registration.)

The week aims to start relevant discussions, introduce new technologies and insights, and share experiences. Over the course of this year to date, a number of companies have made great strides with their urology innovations. Here are 10 stories that caught our eye in the first nine months of 2024 — plus some urology-related podcast episodes.

First, check out these episodes from the DeviceTalks Podcast Network that cover urology

• Imaging pioneer Arun Menawat explains how MR-driven Profound Medical will upend traditional surgery
• GE HealthCare pulls back the curtain on its unmatched AI clearances; Catalyze tackles AI trust gap
• BD’s CTO Shares How Medtech Innovation Helps Patients, Providers
• J&J’s Tezel Says Tapping Global Network and Diverse Engineering Disciplines Strengthens Medtech R&D
• Medtronic Endoscopy’s Chief AI Officer on Transforming Dx through AI and Patient-Centric Design

Now, for MassDevice’s urology coverage…

UroMems raises $47M Series C

Grenoble, France-based UroMems — which has its U.S. headquarter in Minneapolis — brought in a significant funding round to support its smart automated artificial urinary sphincter (AUS) to treat stress urinary incontinence (SUI).

Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to other options.

The company previously had positive early feasibility data in a study of six men, then reported the first-ever female implant earlier this year.

Axonics in the news for a number of reasons

Irvine, California–based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. Axonics also launched the recharge-free F15 SNM system in mid-2022.

The company made waves when it became a key part of one of the biggest medtech M&A plays of the year, as Boston Scientific agreed to pay $3.7 billion to add the Axonics urology technologies to its portfolio. That deal hangs in the balance, though, as the FTC requested additional information regarding the acquisition.

While we await the outcome of that acquisition, Axonics earned a significant IP victory this month when a jury unanimously ruled in its favor in a patent spat with Medtronic. The jury found that Axonics does not infringe on any of the three patents-in-suit related to its tined lead design and temperature sensor technology.

Procept Biorobotics gets FDA’s nod for next-gen surgical robot

In August, Procept Biorobotics said it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system.

Hydros delivers the San Jose, Californi–based company’s Aquablation therapy. The company received FDA investigational device exemption (IDE) for its Aquablation procedure in September 2023. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life.

The image-guided, automated, heat-free robotic therapy uses real-time ultrasound imaging. This provides the surgeon with a multi-dimensional view of the prostate. Aquablation therapy enables personalized treatment planning tailored to each patient’s unique anatomy, Procept Biorobotics says.

Medtronic GI Genius rolls out with next-gen hardware

Cosmo Intelligent Medical Devices announced in August that it received FDA clearance for the next-generation GI Genius hardware distributed by Medtronic. This announcement marked the launch of the sixth generation of the GI Genius hardware, which Medtronic exclusively distributes globally.

GI Genius, a computer-aided polyp detection system powered by AI, has been available in the U.S. since 2021. It was designed to redefine GI screening by assisting gastroenterologists in performing colonoscopies. The latest iteration, rolled out by Cosmo, includes the FDA-cleared ColonPRO software. This AI application helps identify potential polyps and standardize quality metric reporting during colorectal cancer screenings.

The system’s enhanced AI capabilities accelerate the system toward new features. The module can host multiple AI apps, broadening its utility, through a developer program led by Cosmo with Medtronic’s commercial expertise.

Asensus Surgical wins FDA nod for surgical robot use in urology

Research Triangle Park, North Carolina-based Asensus Surgical — which is now a part of Karl Storz — can now offer its Senhance surgical system for the treatment adult and pediatric urology patients following FDA approval in July.

Asensus originally designed Senhance for use in general laparoscopic and laparoscopic gynecological procedures. Senhance has been successfully utilized for urology procedures outside the U.S. for years but can now be used for the U.S. patient population.

Anthony Fernando, Asensus Surgical president and CEO, said: “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. We are excited to bring this technology to urologists and their patients across the United States.”

Olympus expands its urology portfolio

Tokyo-based Olympus advanced its urology offerings a couple of times in 2024, first with the FDA clearance for its RenaFlex single-use ureteroscope system in April.

RenaFlex offers access and visualization in the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones. It helps visualize organs, cavities and canals in the urinary tract via transurethral or percutaneous access routes. Olympus designed RenaFlex for use with endotherapeutic accessories for both diagnostic and therapeutic procedures.

Then, in September, the company launched a new 4K camera head, CH-S700-08-LB, for endoscopic urology and gynecology procedures. Olympus said its product provides four times the number of pixels than a conventional HD camera head. It enables observation with 4K white light images and 4K narrow band imaging (NBI) images. The system also features a blue light observation function for versatile capabilities within a single device, addressing diverse clinical needs.

The company says its camera head supports high-quality diagnosis and treatment of urological disease, including bladder cancer.

GE HealthCare unveils new AI-enabled software for urology

In March, GE HealthCare launched its Prostate Volume Assist (PVA) urology-based AI software feature.

The company designed the software feature to support clinicians in prostate imaging, biopsies and guiding treatment. It assists urologists by improving workflows and quickly capturing prostate volume. The added functionality with PVA helps determine calculations and measurements of the organ with an automated, one-click process.

Measuring prostate volume helps identify and plan treatment for several prostate diseases, including cancer, GE HealthCare said.

Fredrik Gran, head of innovation, surgical visualization and guidance, ultrasound at GE HealthCare, said: “Prostate Volume Assist uses artificial intelligence to automate this process with a single click, and yield results in less than two seconds. This technology provides an added level of support for urologists to improve efficiencies in the workflow and enable precision care.”

Affluent Medical touts first implant of artificial urinary sphincter

Affluent Medical, a France-based company that also makes heart valves, announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device in March.

Dr. Roman Zachoval completed the first implant of Artus, an artificial urinary sphincter. Zachoval, head of urology at Thomayer University Hospital in Prague, implanted Artus in a 68-year-old male patient with severe urinary incontinence.

Affluent Medical designed Artus to treat moderate-to-severe urinary incontinence in both men and women. Patients with the implant can activate the device with a remote control. It then controls the opening and closing of the patient’s urethra, enabling personalized therapy.

Biobot Surgical raises $18M for surgical robot

In March, Biobot Surgical closed a Series B funding round worth $18 million to support its Mona Lisa surgical robot.

The company designed Mona Lisa as a robotic-assisted transperineal needle positioning device for prostate disease management. It delivers a precision percutaneous approach to these procedures. The company hopes to use funds to bring it into the field of benign prostatic hyperplasia (BPH) as well.

Company officials say Mona Lisa is the first and only commercially available robotic positioning device of its kind. It brings with it several regulatory approvals — including FDA approval and CE mark — and has been used in more than 20,000 procedures to date, with more than 50 global installations, he said.

Biobot already introduced Mona Lisa in the U.S., China, Australia, Europe and more Asia Pacific geographies. It also has a joint venture with Microport Medbot to continue its growth in Asia.

Duo of companies developing neuromod tech for urology raise more than $20M apiece

Avation Medical announced in February that it raised $22 million in a Series C financing round to support its Vivally wearable peripheral neuromodulation technology.

Vivally, a non-invasive, FDA-cleared wearable neuromodulation system delivers closed-loop, autonomously adjusted electrical stimulation to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome. The system uses proprietary algorithms and electromyographic sensors. Worn on the ankle, Vivally only requires 30-minute therapy sessions as infrequently as once per week.

In July, San Jose, California-based Neuspera Medical raised $23 million in a Series D funding round. It earmarked the funds to get its implant designed to provide patients with personal control and relief from UUI through the FDA premarket approval process.

The Neuspera System is a non-invasive sacral neuromodulation device that includes an ultra-miniaturized pulse generator attached to an electrode array. It is discreet and can fit within the protected space of the sacral foramen. The company designed it to eliminate the need for more invasive tunneling and a separate pocket for an implanted battery.