A trial is under way in Kansas City in a product liability lawsuit against Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR), marking the 1st time a pelvic mesh lawsuit against 2 companies has gone before a jury, Courtroom View Network reported. Plaintiff Eve Sherrer alleges that Bard’s Align and Boston Scientific’s Solyx used a polypropylene mesh that reacts to tissue by becoming brittle […]
Women's Health
Guided Therapeutics sees FDA path for LuViva cervical scanner
Guided Therapeutics (OTC:GTHP) said today that it believes it struck a “general agreement” for getting its LuViva cervical scanner approved by the FDA. The plan to collect more data on LuViva is slated to be completed over the next 2 to 3 months, Norcross, Ga.-based Guided Therapeutics said. The company said the agreement was hashed out at […]
Fujifilm submits 2nd PMA module for tomosynthesis breast imager
Fujifilm Holdings (TSE:4901) said yesterday it filed a 2nd pre market approval module for a digital breast tomosynthesis upgrade for its Aspire Cristalle mammography system. The company expects to submit the remaining modules for the DBT upgrade, known as Amulet Innovality outside of the U.S., within the coming year. “Digital breast tomosynthesis technology is making a […]
FDA plans Essure action for February
The FDA said today it will issue an evidence-based review of information on Bayer‘s (ETR:BAYN) controversial Essure permanent birth control for women in February next year. The agency said patient health and well-being was its 1st priority regarding the device, and named the issues with Essure specifically as a high-priority issue for it. The federal watchdog […]
Gynesonics tops off $46m round
Gynesonics said the $2.9 million it just added to its coffers closed out a funding round totaling $46 million. The round was led by USP Group’s Novit Ventures and included Endeavour Vision, Abingworth, HealthCrest, InterWest Partners, Advanced Technology Ventures, HBM Partners, Correlation Ventures and Hercules Technology Growth Capital. Redwood City, Calif.-based Gynesonics makes the Sonata radiofrequency ablation device […]
AirXpanders seeks de novo FDA nod for AeroForm
AirXpanders said today it will submit an application for de novo classification with the FDA for its AeroForm tissue expander. The shift comes based upon advice the Palo Alto, Calif.-based company received from the FDA regarding its 510(k) submission, AirXpanders said. The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand […]
House bill would ban Bayer’s Essure
A bill introduced by Rep. Mike Fitzpatrick (R-Pa.) would ban U.S. sales of the Essure female sterilization implant made by Bayer (ETR:BAYN). The “E-Free Act” or H.R. 3920 was introduced Nov. 4 and has 3 co-sponsors: Reps. Marsha Blackburn (R-Tenn.), Gregorio Sablan (I-N. Mariana Islands) and Christoper Smith (R-N.J.). It would direct the FDA commissioner to withdraw approval for the Essure device, the only approved permanent […]
Guided Therapeutics pushes back FDA date for LuViva device
Guided Therapeutics (OTC:GTHP) said today the FDA granted a request to reschedule a meeting to discuss its stalled bid for pre-market approval for its LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s now scheduled to meet with the FDA on Nov. 30 to discuss its plans to submit the application for the cervical scan device. […]
INVO Bioscience wins FDA de novo approval for InvoCell
INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in […]
No timeline on Sientra’s return to breast implant market
There’s no timeline yet for a return to the U.S. market with its breast implants, Sientra (NSDQ:SIEN) CEO Hani Zeini told analysts this week. Earlier this month Sientra put a temporary hold on U.S. sales of implants made by Brazilian contract manufacturer Silimed, after Brazilian regulator Anvisa and the U.K.’s Medicines & Healthcare Products Regulatory Agency had already suspended sales after contamination was detected […]
Boston Scientific settles Salazar pelvic mesh lawsuit
Boston Scientific (NYSE:BSX) asked a Texas state court this week to dismiss a product liability lawsuit brought over its Obtryx pelvic mesh, saying it reached a settlement with the plaintiffs. Martha Salazar claimed that the Obtryx device, implanted in 2010 to treat her urinary incontinence, caused nerve damage, persistent pain and infection that her lawyer said prevents her from […]