INVO Bioscience today announced that a child had been born to a same-sex couple in which both partners were able to carry the baby in separate phases of the pregnancy. The couple, Bliss and Ashleigh Coulter of Mountain Springs, Texas, welcomed their son, Stetson, in late October. The women and their doctors used INVO Bioscience’s […]
Invo Bioscience launches InvoCell in US
INVO Bioscience said today it launched its InvoCell intravaginal culture infertility treatment system in the U.S., starting in Texas through the Center for Assisted Reproduction. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in vitro fertilization which takes place in a laboratory, the company […]
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 […]
Medtronic wins 510(k) for surgical sealer | Regulatory Roundup
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.
Geron’s exit from stem cell business means opportunity for InVivo, others
Wall Street Beat: KCI alters debt deal with Apax – again
Terms for the $6.3 billion leveraged buyout of Kinetic Concepts Inc. (NSYE:KCI) are in flux once again as the debt crisis in Europe roils credit markets.
KCI agreed in July to a $68.50-per-share LBO by Apax Partners and a pair of Canadian pension funds. The London-based PE firm and its partners planned to finance the buyout with about $5 billion in debt, backed by lenders Bank of America Corp., Credit Suisse Group AG and Morgan Stanley.
St. Jude gets Japanese go-ahead for smallest ICD and CRT in the industry
St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.
A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.
INVO Bioscience touts South American infertility treatment trial results
INVO Bioscience (OTC:IVOB) is touting the results of a South American clinical trial it says showed its INVOcell, a small capsule used to incubate eggs and sperm as an alternative to conventional infertility treatments, posted a 36 percent success rate in impregnating infertile women.
The Beverly, Mass.-based company said more than two-thirds of the 50 patients enrolled at the Center of Fertility and Sterility in Bogota, Colombia, reached the study’s endpoint of clinical pregnancy, defined as a fetal heartbeat at seven weeks. That success rate puts the technique on par with other infertility treatments, company officials said, but with a much lower multiple pregnancy rate of 6 percent.
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