Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use ureteroscope system. Marlborough, Massachusetts-based Boston Scientific plans a limited U.S. launch for the digital, flexible ureteroscope system in the coming weeks. The company said in a news release that it’s the first ureteroscope system that can monitor intrarenal pressure […]
Men's Health
FDA approves fourth-gen rechargeable sacral neuromod tech from Axonics
Axonics (Nasdaq:AXNX) announced today that the FDA approved its fourth-generation R20 rechargeable sacral neuromodulation system. The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a […]
Cook Medical launches urological bipolar electrodes porfolio
Cook Medical announced today that it has launched a streamlined portfolio of urological bipolar electrodes in the U.S. The electrodes are for daily use in bladder and prostate procedures. The new portfolio includes seven products. Six have configurations for use in transurethral resection, ablation and soft tissue removal of the prostate and bladder, and where […]
Minerva Surgical CEO retires, former Activ Surgical head Todd Usen named as replacement
Minerva Surgical (Nasdaq:UTRS) announced that it appointed Todd Usen to replace retiring President and CEO David Clapper. Clapper served as president and CEO of the abnormal uterine bleeding (AUB) treatment developer since 2011. Minerva selected Former Activ Surgical CEO Todd Usen to take over those roles and become a member of the board, effective Jan. […]
Medtronic enrolls first patients in Hugo surgical robot clinical trial
Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand URO U.S. clinical trial for the Hugo surgical robot. Dr. Michael R. Abern at Duke University Hospital (Durham, North Carolina) performed the procedure. He used the Hugo robotic-assisted surgery (RAS) system for a robotic-assisted prostatectomy procedure. “This is an exciting moment,” said Abern. […]
UroMems begins first-in-human study of smart implant for treating stress urinary incontinence
UroMems announced today that it completed the first-in-human implant of its UroActive system for treating stress urinary incontinence (SUI). Grenoble, France-based UroMems designed UroActive as a smart, automated artificial urinary sphincter (AUS) investigational device. The company said in a news release that UroActive represents the first smart, automated AUS. Kicking off the clinical study marks […]
Medtronic installs first GI Genius modules in Twin Cities
Medtronic (NYSE:MDT) announced that it completed the installation of 28 GI Genius intelligent endoscopy modules in Minnesota. Fridley, Minnesota-based Medtronic installed the intelligent endoscopy modules at seven MNGI Digestive Health Clinics in the Twin Cities. MNGI Digestive Health specializes in gastrointestinal care. According to a news release, the installations make MNGI the first practice offering […]
Medtronic to install 115 GI Genius modules across VA facilities
Medtronic (NYSE:MDT) announced today that its Gastrointestinal Business received a contract to install GI Genius systems at some Veterans Affairs (VA) facilities. The contract comes through a partnership with a Service-Disabled Veteran-Owned Small Businesses (SDVOSB). Medtronic will install 115 GI Genius intelligent endoscopy modules across numerous VA medical facilities in the U.S. Veterans can now […]
MedAlliance enrolls first patient in study of drug-eluting balloon for treating erectile dysfunction
MedAlliance announced today that it enrolled the first patient in a trial for its drug-eluting ballon in treating erectile dysfunction. Geneva, Switzerland-based MedAlliance said an 82-year-old Taiwanese man enrolled in the initial trial. It will evaluate the Selution SLR sirolimus-eluting balloon for the treatment of erectile dysfunction (ED). Get the full story at our sister […]
Axonics announces first patient implants in Canada for sacral neuromod system
Axonics (Nasdaq:AXNX) today announced the first patient implants in Canada for its Axonics F15 sacral neuromodulation (SNM) system. Irvine, California-based Axonics designed its new F15 as a long-lived, fully recharge-free SNM system. It received Health Canada approval after FDA approval in March. The company’s U.S. launch took place the following month. According to a news […]
Neuspera Medical appoints new CEO
Implantable neuromodulation technology developer Neuspera Medical announced today that Steffen Hovard joined the company as CEO. Hovard most recently served as president of Coloplast’s interventional urology arm. He had leadership responsibilities across four business areas within urological devices. At Coloplast, he oversaw 900 employees across 19 countries. According to a news release, Hovard also serves […]