FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Study: Use of long-acting reversible contraception spiked after 2016 election
In a study published this week in JAMA Internal Medicine, researchers reported that use of long-acting reversible contraception increased in the month following the 2016 presidential election. Adjusting for seasonal trends and patient characteristics, the researchers from Brigham & Women’s Hospital found that insertion of contraceptives such as intrauterine devices increased by 21.6% after the election of President […]
UPDATE: Philly jury hits J&J’s Ethicon with $41m judgment in pelvic mesh case
Updated to include a response from Ethicon. Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $41 million verdict in a pelvic mesh product liability suit in Philadelphia, according to a report from the Mesh News Desk. A jury in Philadelphia found that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defective, and that the company […]
MobileODT touts colposcope-based cervical cancer detection AI
MobileODT said last week that it is implementing a new artificial intelligence algorithm in its EVA system Colposcope that it claims can detect cervical cancer more effectively than existing testing. The new technology, known as Automated Visual Evaluation, has been validated by the National Cancer Institute and the National Library of Medicine, the Israel-based company said, […]
Gynesonics touts 1-year pivotal IDE Sonata trial data
Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said. The company’s flagship Sonata System is a […]
QT Ultrasound launches U.S. ultrasound mammography clinic chain
QT Ultrasound said today that it is launching a chain of commercial mammography scanning centers using its radiation and compression-free breast imaging technology. The Novato, Calif.-based company said the chain will function under the moniker QTbreasthealth, and will provide women a “unique spa-like, patient-centric environment.” The company has already opened locations in Novato, Walnut Creek, […]
IZI Medical picks up Cook Medical’s Quick-Core biopsy and breast localization needle assets
IZI Medical Products extended its M&A spree today with the acquisition of a set of biopsy and breast localization needles from Cook Medical for an undisclosed amount. Last September Chicago-based IZI picked up Benvenue Medical’s vertebral augmentation portfolio, also for an undisclosed amount; in May 2017, the company paid an unspecified price for Cook’s vertebroplasty devices, including the Duro-Ject […]
Atlantic Therapeutics raises $32m Series B for garment-based UI stimulator
Atlantic Therapeutics said yesterday that it raised a Series B round worth $32 million for the garment-based device it makes to treat stress urinary incontinence. Innovo, an externally worn electrical muscle stimulation device, has CE Mark approval in the European Union and recently won de novo clearance from the FDA, Galway, Ireland-based Atlantic Therapeutics said. Clinical […]
Minerva Surgical raises $9m for endometrial ablation tech
Minerva Surgical has raised $9.2 million from 17 investors as part of a $10 million offering, according to a document filed with the SEC this week. The Redwood City, CA.-based company makes the Minerva endometrial ablation system – a treatment designed to help women manage heavy menstrual bleeding. Heaving bleeding, which occurs in women between […]
Gynesonics closes $75m financing round
Gynesonics said today that it closed a $75 million equity financing round to support its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. The round was led by Bain Capital Life Sciences and joined by all the Redwood City, Calif.-based company’s existing investors, including Abingworth, Advanced Technology Ventures, […]
Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery
A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report. The patient, Wendy Knecht, underwent […]
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