SRS Medical Systems said yesterday it won CE Mark approval in the European Union for its Spanner temporary prostatic stent designed to be used as both an indwelling Foley catheter and an intermittent urinary catheter in male patients. The Spanner device consists of a pair of anchors and a silicone tube and is designed to reduce resistance […]
Urology
Axonics launches post-market sacral neuromod OAB study
Axonics Modulation Technologies said today it launched the Relax-OAB 65-patient post-market clinical follow-up study of its SNM system designed to treat overactive bladder. The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, the Irvine, Calif.-based company said. Axonics touted the 1st implants and enrollments […]
Boston Scientific wins UK NICE support for GreenLight laser therapy
Boston Scientific (NYSE:BSX) said Tuesday that the U.K.’s National Institute for Health and Care Excellence now provides guidance supporting the use of its GreenLight XPS laser therapy system used to treat prostatic enlargement in patients with benign prostatic hyperplasia. NICE, which provides evidence-based guidance and standards to the U.K.’s National Health Service, said that adoption of […]
Bluewind Medical wins CE Mark for OAB neuromod device
Neurostim developer Bluewind Medical said today it won CE Mark approval in the European union for its OAB-1000 system designed to treat overactive bladder through wireless neurostimulation. The OAB-1000 device is a wireless, battery-less neurostimulator that is implanted in a minimally invasive procedure near the tibial nerve in the lower leg. The device stimulates the […]
Boston Scientific updates warnings for pelvic mesh products
Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals. The Marlborough, Mass.-based company added new precautions to the directions for the meshes, warning that that “regardless of the route of delivery,” the meshes have been associated with […]
Axonics wins CE Mark for SNM, touts cost-efficacy study
Axonics Modulation Technologies said today it won CE Mark approval in the European Union for its SNM sacral nerve modulation system and announced the publication of a cost-efficacy study of the device in Neurourology and Urodynamics. The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, […]
BrightWater raises $5.2m in Series A to support ConvertX nephroureteral stent
Ureteral medical device company BrightWater Medical said today it closed a $5.2 million Series A round of financing to support its ConvertX Nephroureteral stent system designed for treating severe ureteral obstructions from development to regulatory filing. The ConvertX System is designed as a single device intended to replace a series of devices and procedures used […]
Philips and Profound Medical extend ablation tech deal
Royal Philips (NYSE:PHG) said it extended its deal with Profound Medical to include a sales and marketing agreement to promote Profounds’ Tulsa-Pro ultrasound ablation system. Profounds Tulsa system allows for a minimally invasive, whole-gland ablation of the prostate, which will be guided by Philips MRI machines, the companies said. “Our agreement with Philips will enable us to […]
NeoTract touts 4-year UroLift data
NeoTract today released the results from 2 randomized studies of its UroLift system designed to treat benign prostatic hyperplasia, touting “excellent” durability after 4 years. The data was presented at the American Urological Association’s 2016 annual meeting in San Diego this week. “The clinical data presented at this year’s AUA conference show that treatment with the […]
SonaCare inks marketing deal with Philips’ Invivo biz for its UroNav software
SonaCare Medical said today it inked a marketing alliance deal with Royal Philips (NYSE:PHG) business Invivo to license its UroNav fusion software with its Sonablate planning system. The new deal will allow clinicians to use the UroNav device to annotate and biopsy targeted prostate tissue and localize the tissue appropriate for ablation directly with its […]
Potrero wins FDA 510(k) for Accuryn system
Potrero Medical said today it won FDA 510(k) clearance for its Accuryn monitoring system designed to turn urinary catheters into diagnostic tools. San Francisco-based Potrero’s Accuryn critical care monitoring system uses a urinary catheter to deliver real-time, actionable data on urine output, core temperature and intraabdominal pressure, the company said. “Sepsis and acute kidney injury […]