BlueWind Medical announced that the Centers for Medicare & Medicaid Services (CMS) finalized a favorable payment adjustment for its Revi system. The 2025 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems Rule favorably impacts reimbursement rates for the Park City, Utah-based company’s Revi implantable tibial neuromodulation (iTNM) system. Revi is an […]
Bluewind Medical
BlueWind Medical reports positive data for tibial neuromod
BlueWind Medical today announced two-year data from the OASIS pivotal study of its implantable tibial neuromodulation (iTNM) system. Park City, Utah-based BlueWind said investigators presented data at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week 2024 in Washington, D.C., and the International Continence Society (ICS) 2024 Annual Meeting in Madrid. Data came from […]
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 […]
FDA grants de novo nod to BlueWind Medical’s neuromod for urinary incontinence
BlueWind Medical announced today that the FDA granted a de novo marketing request for its Revi neuromodulation system. Park City, Utah-based BlueWind designed Revi as a tibial neuromodulation system for treating the symptoms of incontinence. It treats urgency incontinence alone or in combination with urinary urgency. De novo approval for men and women with urge […]
BlueWind Medical appoints new CEO
Neurostimulation device company BlueWind Medical has appointed its chairman of the board Daniel Lemaitre as its new CEO, effective last week on Jan. 1. Lemaitre has served as BlueWind Medical’s chairman of the board since November 2018. He’s also a board member of Globus Medical as well as chairman of Endologix. The industry veteran was […]
BlueWind posts positive follow-up study results
Neurostim developer BlueWind Medical reported positive results from a follow-up study of patients using its implantable tibial nerve stimulator for overactive bladder (OAB). Renova iStim is a leadless, miniature, wireless neurostimulation platform designed for the treatment of multiple clinical indications. Three years after implantation of the BlueWind’s Renova iStim device, 75% of patients experienced at least a 50% […]
Hologic CFO McMahon jumps ship to Agilent | Personnel Moves – August 1, 2018
Hologic (NSDQ:HOLX) said yesterday that its CFO Bob McMahon is leaving to take up a CFO role at Agilent Technologies. The Marlborough, Mass.-based company said that its current chief accounting officer Karleen Oberton has been lifted to CFO, effective today. “Bob has made tremendous contributions to Hologic over the last four years, and we wish him […]
MRI Interventions taps ex-Philips exec Burnett as prez, CEO | Personnel Moves – Oct 19, 2017
MRI Interventions (OTC:MRIC) said early this month it tapped former Royal Philips (NYSE:PHG) neuro diagnostics & therapy biz GM Joseph Burnett as its new prez & CEO, effective November 7. Burnett will replace Frank Grillo who will stay in his role until November 6 and will continue to serve as an executive advisor afterwards, the Irvine, Calif.-based […]
Bluewind Medical wins CE Mark for Vivendi mini-neurostim pain implant
Neurostim developer Bluewind Medical said today it won CE Mark approval in the European Union for its Vivendi neurostimulation device designed to treat peripheral neuropathic pain. The newly cleared neurostim device is 90% smaller than ‘typical’ neurostimulators on the market, the Israeli company said, and is designed to be implanted in close proximity to the Tibial […]
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 […]
