Sequana Medical announced today that CMS recommended that its Alfapump system become eligible for a new incremental payment. Alfapump treats these fluid overload conditions that arise due to liver cirrhosis and malignant ascites. The fully implantable, wirelessly charged device continuously collects ascites as it forms in the abdominal cavity. It then moves into the bladder, […]
Urology
Bright Uro wins FDA nod for Glean urodynamics system
Bright Uro announced today that it received FDA 510(k) clearance for its Glean urodynamic analyzer system. Glean, a comprehensive system, enables wireless, catheter-free urodynamics. Bright Uro aims to provide clinicians with more accurate data and actionable insights to aid in clinical decision-making. Glean features an insertion tool and a Bluetooth-enabled pressure sensor in a flexible […]
Head-to-head study backs Teleflex UroLift system against Boston Scientific’s Rezūm
Teleflex today announced new data highlighting the success of its UroLift benign prostatic hyperplasia (BPH) treatment system. Investigators presented findings from the CLEAR study at the 40th Annual European Association of Urology (EAU) Congress in Madrid. Results showed better early patient satisfaction and sexual function with UroLift compared to Rezūm water vapor therapy. Boston Scientific […]
Calyxo reports death related to aspiration system issue
The FDA has issued a notice warning of a potential issue with the CVAC aspiration system marketed by Calyxo. This communication comes as part of an FDA pilot to enhance its medical device recall program. The FDA issued its notice after becoming aware of a potentially high-risk device issue. Calyxo sent affected providers an urgent […]
NanoVibronix announces reverse stock split
NanoVibronix (Nasdaq:NAOV) announced today that it intends to effect a reverse stock split of its common stock. The split comes at a ratio of one post-split share for every 11 pre-split shares. Tyler, Texas-based NanoVibronix expects the split to go into effect at 4:05 p.m. on March 13, 2025. It plans for its common stock […]
Neuspera has positive sacral neuromod data
Neuspera Medical today announced six-month pivotal clinical trial data highlighting the efficacy of its battery-free percutaneous sacral neuromodulation (pSNM) system. Findings showed comparable efficacy with the pSNM system against traditional sacral neuromodulation (SNM) devices. it also aims to offer a significantly better patient experience for the treatment of urgency urinary incontinence (UUI). San Jose, California-based […]
UroMems reports positive outcomes in first-ever female-only study of smart implant for incontinence
UroMems announced that the entire treatment cohort in the first-of-its-kind study in female patients successfully reached its primary endpoints. Grenoble, France-based UroMems — which has its U.S. headquarters in Minneapolis — develops an implantable system called UroActive. Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in […]
Valencia Technologies raises $35M for coin-sized neuromod device, picks new CEO
Valencia Technologies announced today that it received a strategic investment totaling up to $35 million and appointed a new CEO. The neuromodulation company focused on treating urinary incontinence named James D. Surek as its new CEO. Valencia plans to leverage its new capital and Surek’s commercial leadership experience to fuel the growth of its eCoin […]
Medtronic, Boston Scientific settle Axonics IP dispute
Medtronic and Axonics — now part of Boston Scientific — have confidentially settled their long-running IP dispute. Legal news sites, including Bloomberg Law, were the first to break the news this week. A Medtronic spokesperson provided the following statement to MassDevice today: “Medtronic and Boston Scientific are pleased to have reached a confidential settlement agreement that will resolve […]
Levee Medical raises $14M for urologic scaffold
Levee Medical announced today that it closed its Series B financing, bringing in proceeds of more than $14 million. The Durham, North Carolina-based company plans to use funds to accelerate the development of its Voro urologic scaffold. It designed the device to reduce post-prostatectomy urinary incontinence. Funds could support ongoing clinical studies, including an upcoming […]
Dentsply Sirona to consider strategic alternatives for Wellspect Healthcare business
Dentsply Sirona (Nasdaq:XRAY) announced today that it initiated a process to evaluate strategic alternatives for its Wellspect Healthcare business. Wellspect provides bladder and bowel management care products. The business, situated in what Dentsply considers a $2 billion continence care space, delivered mid-to-high single-digit sales growth over the past couple of years. Simon Campion, Dentsply Sirona’s […]
