Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems. Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, […]
Urology
Corinth MedTech receives $5M venture loan
Horizon Technology Finance Corporation announced yesterday that it provided a $5 million venture loan to Corinth MedTech. San Jose, Calif.-based Corinth develops the FDA-cleared Veloxion system for treating symptoms related to benign prostatic hyperplasia (BPH), also known as TURP for enlarged prostate, according to a news release. Veloxion includes a resectoscope with an integrated camera, […]
Boston Scientific launches product for prostate cancer patients
Boston Scientific (NYSE:BSX) announced today that it has launched a product to help reduce radiation side effects in prostate cancer patients. The SpaceOAR Vue hydrogel is designed to create a temporary space between the prostate and rectum during radiation therapy, according to a news release. The hydrogel’s use also enables radiology staff to use computerized tomography […]
Ex-Sanovas CEO sentenced to 11+ years in fraud case
Former Sanovas president & CEO Larry Gerrans was sentenced yesterday to 135 months in prison for wire fraud and money laundering in connection with a scheme to defraud the medical device company. U.S. District Judge Edward M. Chen handed down the sentence following a guilty verdict after a two-week trial in San Francisco in January 2020. The […]
Medtronic issues safety notice for InterStim SureScan MRI leads
Medtronic (NYSE:MDT) recently issued an urgent field safety notice to alert users to a potential issue with its InterStim SureScan MRI leads. Fridley, Minn.-based Medtronic said in the notice out of Germany that the Medtronic Model 3560030/3560022 percutaneous extension is intended for use with the Model 978A1/978B1 InterStim SureScan MRI leads during an advanced evaluation to […]
Axonics launches SNS postmarket study
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 […]
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. […]
