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 […]
Gynecological
Hologic launches hysteroscopy system
Hologic (NSDQ:HOLX) announced today that it launched the Omni suite for optimizing diagnostic and operative hysteroscopy. Marlborough, Mass.-based Hologic’s newly launched suite includes the Omni 30° hysteroscope along with Omni 4K video technology to complement its existing portfolio of GYN surgical solutions, according to a news release. The new Omni hysteroscope offers diagnostic and operative versatility […]
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 […]
Bard prevails in pelvic mesh trial
The Supreme Court of Missouri ruled in favor of Becton Dickinson’s (NYSE:BDX) C.R. Bard business in a lawsuit alleging liability issues with its pelvic mesh. In 2013, Eve Sherrer filed claims over polypropylene mesh slings that she’d had implanted in 2011 and 2012 to treat urinary incontinence, including claims for negligence, design and manufacturing defects, and […]
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 […]
BD is paying $60M to settle Bard pelvic mesh suits with most U.S. states
Becton Dickinson (NYSE:BDX) will pay $60 million to 48 U.S. states to resolve allegations that its C.R. Bard business deceptively marketed transvaginal surgical mesh devices, state attorneys general in California and Washington announced today. Mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs, but they instead sparked […]
Viveve gains stress urinary incontinence tech patent
Viveve Medical (NSDQ:VIVE) announced that the U.S. Patent & Trademark Office issued a patent for its stress urinary incontinence technology. USPTO issued U.S. Patent No. 10,779,874, allowing Viveve to expand its intellectual property portfolio ahead of its U.S. pivotal Pursuit clinical trial evaluating its treatment of SUI in women, according to a news release. Englewood, Colo.-based […]
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 […]
Hologic buys Accessa Health for $80M
Hologic (NSDQ:HOLX) announced that it acquired fibroid treatment developer Acessa Health in a deal worth approximately $80 million. Austin, Texas-based Acessa markets the Acessa ProVu fully integrated laparoscopic system for combining radiofrequency ablation with intra-abdominal ultrasound visualization and guidance mapping for treating women with symptomatic, benign uterine fibroids. Marlborough, Mass.-based Hologic said in a news release […]
