Gynesonics has announced the full U.S. and European launch of its Sonata 2 transcervical fibroid ablation system for incisionless, uterus-preserving procedures. The Sonata 2 system is the world’s first and only transcervical fibroid ablation system to combine intrauterine ultrasound guidance with targeted radiofrequency energy in the incisionless procedure, according to a Nov. 11 news release. […]
Invo Bioscience signs European distribution deal
Invo Bioscience (OTCQB:IVOB) announced that it entered into commercialization agreements covering Turkey and Jordan to support the company’s expansion into Eurasia. The commercialization agreements are in place to spread the Lakewood Ranch, Fla.–based company’s InvoCell in vivo fertility system to the Eurasia area. Invo Bioscience said research shows that an estimated 15% to 20% of the […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Hologic launches Definity cervical dilator
Hologic (NSDQ:HOLX) said it has launched its Definity cervical dilator for accessing uterine cavities without a tenaculum. The device uses SureAccess balloon technology to access the cavities to lessen patient discomfort and reduce the risk of perforation during dilation, was soon to hit the market, according to the Marlborough, Mass.-based company. The Definity dilator is […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
INVO Bioscience prices $13m offering
INVO Bioscience (OTCQB:IVOB) yesterday registered a common stock offering of more than $13 million, according to a regulatory filing. The Lakewood Ranch, Fla.-based company is putting up nearly 41 million shares of its common stock for close to $13.1 million. There are currently nearly 39 million outstanding shares, according to the filing. They are traded […]
J&J’s Ethicon loses pelvic mesh appeal in Pennsylvania
The Pennsylvania Supreme Court has upheld a $2.43 million verdict against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a pelvic mesh injury case. Sharon Beltz and her husband, Walter Beltz Jr. of Pen Argyl, Penn., won the verdict in 2017 based on their complaint that Sharon Beltz had suffered injuries due to mesh erosion and […]
Titan Medical delays timeline on Sport robot-assisted surgery device
Titan Medical (TSX:TMD;OTC:TITFX) today pushed back the timeline on its Sport robot-assisted surgery device, saying it now expects to file for 510(k) clearance from the FDA next year, sending its share prices down in New York and Toronto. With a successful human factors evaluation of the single-port device under its belt, the Toronto-based company said […]
Facing delisting, Viveve announces $6.76m funding round
Viveve (NSDQ:VIVE) said last week that it is looking to raise up to $6.76 million in a common stock offering, according to a regulatory filing. The stock is being offered at $0.13 per share, which was the last reported sale price of its common stock on August 15, 2019. The actual number of shares issued […]
AblaCare raises $11.3 million, appoints CEO
Infertility treatment company AblaCare said today that it has raised €10 million ($11.3 million) in Series A financing from Sofinnova Partners and the appointment of medtech veteran Jodie Fam as CEO. The Paris-based company’s minimally invasive ablation technology was designed to treat polycystic ovarian syndrome (PCOS) as an alternative to a surgical method known as […]
J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports. The award includes $50 million in punitive damages and $30 million in compensatory damages — the largest compensatory damages verdict to date in a pelvic mesh case, a company […]
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