The FDA announced today that it authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with indication for performing benign hysterectomy with salpingo-oophorectomy, according to an FDA news release. Using minimally invasive surgical instruments inserted through the vagina and a video […]
Gynecological
Axonics acquires Contura and its Bulkamid bulking agent for $235M
Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million. London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural […]
FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads
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, […]
Federal lawsuit over Boston Sci pelvic mesh heads to trial
A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial. Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009. Cline’s case was recently transferred to federal court in Arkansas […]
CooperSurgical acquires Aegea Medical and its water vapor ablation system
CooperCompanies’ (NYSE:COO) CooperSurgical business has purchased Aegea Medical, nearly a year after Aegea secured FDA approval for its Mara water vapor ablation system for treating heavy menstrual bleeding. The financial terms of the deal were not disclosed in the companies’ announcement yesterday. The companies pointed out an international, multi-center pivotal clinical trial enrolling 155 women, […]
Hologic and Google Cloud team up on digital diagnostics for cervical cancer
Hologic (NSDQ:HOLX) has entered into a multi-year deal to use Google Cloud’s machine learning and deep learning technologies with its Genius digital diagnostics system, a cytology platform that uses volumetric imaging data to identify precancerous lesions and cancer cells of the cervix. The machine learning and deep learning capabilities from Google Cloud will enable Hologic […]
FDA updates power morcellator warnings for fibroid procedures
The FDA today recommended that manufacturers of laparoscopic power morcellators, which have been implicated in the spread of cancer, add noticeable and easy-to-read boxed warnings about the risks in using the devices in gynecologic procedures. In its final guidance on the topic, the agency recommends that laparoscopic power morcellation (LPM) be limited to use with certain tissue containment […]
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 […]
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 […]
