Gynecological Archives - Page 17 of 19

INVO Bioscience touts South American infertility treatment trial results

February 5, 2010 By MassDevice staff Leave a Comment

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.

Hologic’s Q1 bottom line drops 31 percent

February 2, 2010 By MassDevice staff Leave a Comment

Hologic Inc. (NSDQ:HOLX) took another tangible hit to its bottom line, writing off about $100 million worth of intangibles during the first quarter.

In all, the Bedford, Mass.-based women’s health company peeled off a little more than $100 million worth of intangible assets, an accounting term for the value of the perceived advantage a company has over its competitors. The hit, combined with another $18 million charge to adopt new changes to its accounting code, pushed Hologic’s bottom line down 31 percent during the three months ended Dec. 26, 2009.

Judge: Ethicon must produce documents in Mentor Corp. product liability case

January 19, 2010 By MassDevice staff Leave a Comment

A federal judge in Georgia ordered Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery to produce documents subpoenaed in a product liability lawsuit against another J&J subsidiary, Mentor Corp.

Hologic settles with EPA over Wisconsin Third Wave site for $87,400

January 14, 2010 By MassDevice staff Leave a Comment

Hologic Inc. (NSDQ:HOLX) inked a deal with the U.S. Environmental Protection Agency to settle alleged hazardous waste violations at a Third Wave Technologies facility in Madison, Wis.

The Bedford, Mass.-based women’s health products company, which bought Third Wave in 2008 for $580 million, agreed to pay an $87,400 penalty to settle the case.

Philips warns on fetal monitors at FDA’s behest

January 7, 2010 By MassDevice staff Leave a Comment

The Food & Drug Administration prompted Philips Healthcare (AEX:PHI) to issue a voluntary recall notice on four models of its Avalon fetal monitor after receiving complaints that the devices were providing inaccurate readings.

The Dutch company, which houses its U.S. headquarters in Andover, Mass., received numerous complaints about Avalon monitor models FM20, FM30, FM40 and FM50.

Georgia judge: Mentor Corp. execs’ depositions fair game

December 4, 2009 By MassDevice staff Leave a Comment

A federal judge in Georgia decided to allow depositions by Mentor Corp. founder and CEO and its president in a product liability lawsuit, after an earlier decision to reverse his previous ruling and send the case back to a New Jersey court.

Judge Clay Land of U.S. District Court for Middle Georgia initially ruled in August that Geraldine Doria was not entitled to punitive damages in her lawsuit against the company, which made the ObTape transobturator vaginal sling until March 2006. Land found that Food & Drug Administration approval preempts states’ rules on medical device company liability.

Federal judge reverses punitive damages ruling in Mentor Corp. liability case

December 1, 2009 By MassDevice staff Leave a Comment

A federal judge in Georgia reversed his decision to throw out a New Jersey woman’s chance at punitive damages from Mentor Corp., sending the case back to the Garden State.

Judge Clay Land of the U.S. District Court for Middle Georgia initially ruled that Geraldine Doria is not entitled to punitive damages in her lawsuit against the company, which made the ObTape transobturator vaginal sling until March 2006. Land found that Food & Drug Administration approval preempts states’ rules on medical device company liability.

Federal judge deals blow to Conceptus infringement suit against Hologic

November 12, 2009 By MassDevice staff Leave a Comment

A federal judge in California dealt a blow to a Conceptus Inc. (CPTS) lawsuit against Hologic Inc. (HOLX), alleging infringement of five patents for its Essure female sterilization system.

Essure, the Mountain View, Calif.-based company’s sole product, uses a flexible coil partly made of copper to permanently block the fallopian tubes. The device is delivered via a trans-cervical catheter.

Hologic names new CEO as it closes out the year

November 9, 2009 By MassDevice staff Leave a Comment

Jack Cumming’s tenure in the corner office at Hologic Inc. is over, as the 63-year-old exec steps aside to make way for Rob Cascella, the company’s current president and COO.

Hologic said Cumming, who has held his post since 2001, will retain his post as chairman of the board of directors. In his eight years at the helm of the Bedford, Mass.-based women’s healthcare products firm, Hologic grew from $75 million in annual sales to more than $1.6 billion.

JAMA: Hologic’s ThinPrep no more effective than Pap smear

October 30, 2009 By MassDevice staff Leave a Comment

A multi-year study of nearly 90,000 women in the Netherlands shows that Pap smears are just as effective as ThinPrep liquid cytology tests in detecting signs of cervical cancer, according to the Journal of the American Medical Association.

BioSphere’s Q3 sales jump 7 percent as net loss narrows

October 29, 2009 By MassDevice staff Leave a Comment

BioSphere Medical Inc. continued to boost sales and cut expenses as it moved closer to the break-even point during the third quarter.

The Rockland, Mass.-based microsphere maker posted sales of $7.7 million during the three months ended Sept. 30, up 6.8 percent compared with the same period last year. Net losses narrowed 84.6 percent to $216,000, compared with net losses of $1.4 million during the third quarter of 2008.