Axonics Modulation Technologies (NSDQ:AXNX) announced today that it is launching a post-market clinical registry study for its r-SNM system. Irvine, Calif.-based Axonics’ implantable sacral neuromodulation (SNM) system is designed for treating urinary and bowel dysfunction with a battery life of 15 years or more. The Axonics Sacral Neuromodulation System Registry (Artistry) study is a prospective, multicenter […]
Men's Health
First patient implanted with Medtronic InterStim Micro
Medtronic (NYSE:MDT) announced today that the first patient was implanted in the study of its InterStim Micro SNS system. Fridley, Minn.-based Medtronic’s Elite study of the rechargeable InterStim Micro SNS (sacral neurostimulation) system includes all SNS indications for symptoms of overactive bladder, including urinary urge incontinence (UUI) and urinary frequency (UF), along with non-obstructive urinary retention […]
Coloplast invests $4M in Francis Medical
Urological cancer treatment developer Francis Medical announced today that it received a $4 million equity investment from Coloplast (CPH:COLO-B). Minneapolis-based Francis Medical develops ablation technology designed to apply thermal energy stored in sterile water vapor to deliver targeted treatments to the cancerous tissue in a transurethral procedure, according to a news release. The procedure potentially minimizes […]
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced today that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. amid the COVID-19 pandemic. UroShield […]
Vessi Medical raises $1.7m for cryoablation therapy
Vessi Medical announced today that it raised $1.7 million in funding for its cryoablation treatment for superficial bladder cancer. Agriline, the Trendlines Group, the Israel Innovation Authority and ExitValley investors all participated in the financing round to support the minimally invasive treatment, according to a news release. Misgav, Israel-based Vessi Medical touts its cryoablation solution, […]
FDA approves new Medtronic neurostim leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads. Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind. […]
AdaptHealth prices $124m upsized offering
AdaptHealth (NSDQ:AHCO) announced today that it upsized and priced an underwritten offering of common stock at approximately $124 million. Plymouth Meeting, Pa.-based AdaptHealth is offering 8 million shares of its Class A common stock at $15.50 per share. The maker of home medical equipment, supplies and related services had previously set the offering at 6.5 […]
Boston Scientific touts SpaceOAR meta-analysis results
Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
UroMems raises $17.6m
Electronic artificial urinary sphincter (eAUS) maker UroMems announced today that it raised $17.6 million (€16 million) in an equity and debt financing. Grenoble, France-based UroMems intends to use the proceeds from the funding to support ongoing preclinical studies and the initiation of the first clinical studies of its eAUS device for treating stress urinary incontinence […]
Olympus lands FDA de Novo approval for benign hyperplasia device
Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]
Ibex wins CE Mark for AI-powered cancer detection software
Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies. Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology […]
