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Gynecological

FDA approves first robot-assisted system for transvaginal hysterectomy

March 1, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Robotics, Surgical, Women's Health Tagged With: FDA, Memic Innovative Surgery, robot-assisted

Axonics acquires Contura and its Bulkamid bulking agent for $235M

February 25, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Gynecological, Mergers & Acquisitions, Pharmaceutical, Women's Health Tagged With: Axonics Modulation Technologies, Contura Inc., hydrogels

FDA approves expanded labeling for Medtronic InterStim SureScan MRI leads

February 18, 2021 By Sean Whooley Leave a Comment

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, […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Imaging, Men's Health, Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance, Urology, Women's Health Tagged With: FDA, Medtronic

Federal lawsuit over Boston Sci pelvic mesh heads to trial

February 17, 2021 By Chris Newmarker Leave a Comment

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 […]

Filed Under: Featured, Gynecological, Legal News, News Well, Product Liability, Women's Health Tagged With: Boston Scientific, pelvic mesh, Pelvic Mesh Lawsuits

CooperSurgical acquires Aegea Medical and its water vapor ablation system

February 3, 2021 By Chris Newmarker

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, […]

Filed Under: Business/Financial News, Featured, Gynecological, Mergers & Acquisitions, Surgical, Women's Health Tagged With: Aegea Medical, aegeamedical, CooperSurgical, The Cooper Cos.

Hologic and Google Cloud team up on digital diagnostics for cervical cancer

February 2, 2021 By Brian Buntz

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 […]

Filed Under: Big Data, Digital Health, Featured, Gynecological, Health Technology, Software / IT, Women's Health Tagged With: AI, Alphabet (Google), artificial intelligence, cervical cancer, deep learning, Hologic, machine learning

FDA updates power morcellator warnings for fibroid procedures

December 29, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Gynecological, Regulatory/Compliance, Women's Health Tagged With: FDA, powermorcellators

Ex-Sanovas CEO sentenced to 11+ years in fraud case

November 6, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Gynecological, Legal News, Otolaryngology/Ear, Nose & Throat (ENT), Respiratory, Urology, Women's Health Tagged With: Sanovas, U.S. Attorney

Hologic launches hysteroscopy system

November 5, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Gynecological, Imaging, Women's Health Tagged With: Hologic

Medtronic issues safety notice for InterStim SureScan MRI leads

October 23, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Gynecological, Men's Health, Neurological, Neuromodulation/Neurostimulation, Urology, Women's Health Tagged With: Medtronic

Axonics launches SNS postmarket study

October 20, 2020 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Gynecological, Men's Health, Neurological, Neuromodulation/Neurostimulation, Urology, Women's Health Tagged With: Axonics Modulation Technologies

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