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 […]
UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure
Updated to include response from Bayer. The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device. In an official posting, FDA Commissioner Dr. Scott […]
Allergan pulls textured breast implants from the European market
Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee […]
Hologic touts win in trade secret case
Hologic (NSDQ:HOLX) yesterday touted a win in a court case against a Chinese competitor and former employee the company accused of misappropriating trade secrets. The Marlborough, Mass.-based company said that a Massachusetts Superior Court granted a preliminary injunction against Chinese X-ray device maker Direct Digital Imaging Technology and former employee Lawrence Ibbetson for alleged misappropriation of […]
Seno Medical Instruments touts Imagio breast cancer subtype ID trial results
Seno Medical Instruments today released results from a study of its Imagio opto-acoustc imaging system intended to diagnose breast cancer, touting that both morphologic and functional OA/US features serve as a non-invasive approach to helping distinguish breast cancer molecular subtypes. Results from the study were presented late last month at the Radiological Society of North […]
FDA advisory panel to mull transvaginal mesh
The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse. According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the […]
Hologic wins FDA nod, launches next-gen Omni hysteroscope
Hologic (NSDQ:HOLX) said today that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month. The newly cleared Omni hysteroscope features a three-in-one modular scope and is intended for both diagnostic and therapeutic procedures, the Marlborough, Mass.-based company said. “Experts agree that direct visualization of the uterine […]
Viveve prices $20m offering
Viveve (NSDQ:VIVE) last week priced a follow-on offering worth $20 million. Englewood, Colo.-based Viveve’s eponymous device uses cryogen-cooled monopolar radiofrequency tech designed to treat gynecological conditions. The company said Dec. 6 that it floated 13.3 million shares at $1.50 apiece, for gross proceeds of $20.0 million. The offering includes a 30-day underwriters option on another 2.0 […]
Report: FDA-reported breast implant injuries kept hidden by summary reporting
The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser. Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly […]
FDA clears Thermi in “vaginal rejuvenation” product inquiry
Temp-controlled radiofrequency tech developer Thermi said this week that the FDA granted it a notice of completion following an inquiry on products used in “vaginal rejuvenation” procedures. Irving, Texas-based Thermi received a notice from the FDA on July 24 regarding specific claims about the company’s ThermiVa device. The ThermiVa is a non-ablative RF device cleared […]
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