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 […]
Men's Health
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 […]
Urologix successor details dissolution plans
The successor to Urologix said today that it plans to completely dissolve during 2017, spelling the end for the Minneapolis-based urology device maker. Urologix, which made the Cooled ThermoTherapy and Prostiva RF devices to treat benign prostatic hyperplasia, licensed Prostiva from Medtronic (NYSE:MDT). But after running up a $2.8 million tab on its Twin Cities neighbor, Urologix couldn’t come up […]
EmboMedics raises $4.3m for embolization microbeads
EmboMedics said it raised a $4.3 million Series A1 round for the bioresorbable embolization microspheres it’s developing. Maple Grove, Minn.-based EmboMedics said it plans to use the proceeds to pursue pre-market approval for a drug-delivery device, co-founder & CEO Omid Souresrafil said in prepared remarks. The infusion is enough to carry the company through 2018, Souresrafil said. […]
Plaintiff’s lawyers ask FDA to ban Boston Scientific’s pelvic mesh
The law firm that’s bringing a racketeering lawsuit against Boston Scientific (NYSE:BSX) accusing it of smuggling counterfeit resin asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin. Teresa Stevens sued Boston Scientific in January, alleging that the Marlborough, Mass.-based company conspired with subsidiaries in Belgium and Ireland to use counterfeit resin imported from China […]
FDA updates on Boston Scientific surgical mesh implant “counterfeit” material
The FDA today released an update on allegations that Boston Scientific‘s (NYSE:BSX) urogynecologic surgical mesh may contain counterfeit raw material. The agency said it was “examining these allegations” to determine the next steps, but said it is currently not away that the alleged counterfeit raw material is contributing to adverse events with the products. “It […]
Medtronic launches Nuro overactive bladder treatment
Medtronic (NYSE:MDT) said today it launched its Nuro system designed for treating overactive bladder with symptoms of urinary urgency, urinary frequency and urge incontinence. The Fridley, Minn.-based company said the device is designed to deliver percutaneous tibial neuromodulation treatment, a minimally invasive office-based procedure which provides a “measurable reduction” in urinary frequency or urinary incontinence. “Many people with […]
Intuitive Surgical touts cost study on robot-assisted prostate surgery
Intuitive Surgical (NSDQ:ISRG) is touting a study comparing the cost of prostate surgery using its da Vinci robot-assisted surgery device with traditional open surgery. The study, published in the journal Value in Health, assessed hospital costs, payers’ expenditures and societal expenses related to each procedure. The results showed that the robot-assisted surgery delivered shorter hospital stays, lower […]
NeoTract launches MedLift trial
NeoTract said Monday it enrolled the 1st patient in its MedLift U.S. investigational device exemption trial of its UroLift system for treating patients with benign prostatic hyperplasia. The new study from Pleasanton, Calif.-based NeoTract will be conducted across 8 sites in the U.S. and will examine the safety and efficacy of the UroLift system for […]
Boston Scientific releases ureteral stent tracker app
Boston Scientific (NYSE:BSX) has launched a new app designed to help urologists track ureteral stents implanted in patients with kidney stones. The app was developed as a joint operation between the Marlborough, Mass.-based medical device company and digital healthcare tool developer Visible Health, according to the company’s website. The tracker is designed to address issues with retained […]