Olympus today announced positive changes to commercial payer policies covering patients who could benefit from its iTind procedure. iTind treats symptoms of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), or enlarged prostate. Aetna updated its Clinical Policy Bulletin 0079 for Benign Prostatic Hyperplasia to include the iTind procedure as medically necessary […]
Urology
FTC wants more info on Boston Scientific, Axonics deal with closing timeline pushed back
Boston Scientific said today that the FTC requested additional information regarding its planned $3.7 billion acquisition of Axonics (Nasdaq:AXNX). In an SEC filing, Boston Scientific said both it and Axonics received requests from the FTC (U.S. Federal Trade Commission). The agency seeks to gather more information in connection with its review of the merger. Reports […]
Olympus wins FDA clearance for its first single-use flexible ureteroscope
Olympus announced today that the FDA granted 510(k) clearance for its RenaFlex single-use ureteroscope system. The company expects to begin a full-market rollout at a later date. 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 […]
Teleflex launches UroLift 2 with advanced tissue control
Teleflex announced today that it launched the advanced tissue control (ATC) feature on its UroLift 2 system. Wayne, Pennsylvania-based Teleflex designed UroLift 2 to treat benign prostatic hyperplasia (BPH) symptoms in men with all prostate types up to 100g. Adding the ATC capabilities to the platform mark a significant advancement in BPH care, Teleflex said […]
GE HealthCare unveils AI-enabled urology software
GE HealthCare announced today that it 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 […]
FDA clears redesigned kidney stone treatment tech from Calyxo
Calyxo announced today that it received FDA clearance for its new, redesigned CVAC system for minimally invasive kidney stone treatment. Pleasanton, California–based Calyxo’s CVAC system uses irrigation and aspiration to remove kidney stones. The design aims to minimize residual stone burden. CVAC’s original design, which used steerable ureteroscopic renal evacuation (SURE) already successfully treated more […]
Affluent Medical touts first implant of artificial urinary sphincter
Affluent Medical today announced the successful first-in-human implant of its minimally invasive urinary incontinence treatment device. 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. The procedure lasted about 80 […]
Biobot Surgical secures $18M Series B for Mona Lisa surgical robot
Biobot Surgical announced today that it closed a Series B funding round worth $18 million to support its surgical robot. Tony Tan, a healthcare entrepreneur, led the round for the robotic-assisted transperineal biopsy and treatment company. Existing shareholder Zig Ventures also participated. Biobot plans to use the funds raised to accelerate its global expansion and […]
BlueWind reports first patient treated in study of neuromod for urinary incontinence
BlueWind Medical announced today that a doctor treated the first patient in the RESTORE study of its Revi iTNM device. Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, treated the first patient. The prospective, multi-center, open-label, post-market, randomized controlled trial aims to recruit 150 patients across up to 20 U.S. centers. BlueWind designed Revi […]
UroMems has positive results for first-ever female implant of smart urinary sphincter system
UroMems announced today that it successfully met the six-month primary endpoint for the first female patient implanted with UroActive. Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI. Powered by a MyoElectroMechanical system (MEMS), UroActive […]
Vessi Medial raises $16.5M for cryotherapy for bladder cancer
Vessi Medical announced today that it closed a Series A financing round worth $16.5 million to support its cryotherapy technology. Misgav, Israel-based Vessi develops its technology to treat non-muscle invasive bladder cancer (NMIBC). It could provide a therapeutic alternative to transurethral resection of bladder tumor (TURBT), the current first-line therapy. Vessi believes its bladder-specific, proprietary […]