The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Solace Therapeutics Inc. won CE Mark approval in the European Union for its intravesical system to treat female stress urinary incontinence.
The Framingham, Mass.-based medical device maker said its device is a small, quarter-sized balloon that floats inside the bladder. Inserted via catheter during an out-patient procedure, the balloon is designed to relieve the pressure fluctuations within the bladder that lead to incontinence.
Hologic Inc. won CE Mark approval in the European Union for its ThinPrep integrated imager for cervical cancer.
The Bedford, Mass.-based women’s health products maker said the approval clears the way for it to bring the device to market in the EU’s 27 member countries, plus the three European Free Trade Assn. members and other nations that recognize the mark.
Hologic Inc. notched an approval win in the United Kingdom, clearing the way for that nation’s National Health Service to cover its Adiana female sterilization treatment.
The U.K.’s National Institute for Health and Clinical Excellence approved the procedure, which involves threading an endoscope through the vagina, cervix and uterus into the fallopian tubes, where radiofrequency energy is applied to small sections of the tube.
The catheter delivers about 3 watts of energy for roughly 60 seconds in order to create a tiny, shallow lesion in the fallopian tube. A small, silicon matrix plug with a solid core is then inserted at the site to block ova from contact with sperm.
A federal judge threw out a New Jersey woman’s chance at punitive damages from Mentor Corp., finding that Food & Drug Administration approval pre-empts states’ rules on medical device company liability.
Judge Clay Land of the U.S. District Court for Middle Georgia 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.
Turn your post-op recovery into a fashion statement: With designer Olivier Trillon’s concepts, you can choose between an Yves Saint Laurent or Chanel IV bag for your post-op morphine drip. 
Hologic Inc. is touting a British study showing that testing pregnant women for a protein produced by the fetus can affect the way doctors treat their patients.
The market for big-ticket capital equipment will drag for about another year, Hologic CEO Jack Cumming told the Reuters news service.
“We see it continuing as a very tough climate to be selling capital equipment in, at least for the next year,” Cumming said. “I expect, from an economic standpoint, a very slow recovery.”
Hologic Inc. took a 32 percent hit to its bottom line during the third quarter, as its Cytyc and Third Wave Technologies acquisitions continue to weigh down its fiscal 2009 performance.
The Bedford-based women’s health products maker reported $41 million in net income on $403 million in sales during the three months ended June 30, a 32 percent drop from the $61 million the company reported on $430 million in sales during the same period last year.
Customer outreach and other marketing efforts may be starting to pay off for Biosphere Medical Inc.
The Rockland, Mass.-based maker of microscopic polymer beads reported $8.1 million in sales during the three months ended June 30, with a 13 percent jump in U.S. sales of the company’s interventional gynecology products pacing much of that gain.
The net loss for the period was $677,000, which compares with a $1.3 million loss on $7.6 million in sales during the June 2008 quarter.
Hologic Inc. said 1 million women have undergone its NovaSure global endometrial ablation treatment.
The system is used to treat menorrhagia, or heavy menstrual bleeding, using a 90-second burst of low-frequency radio energy in a roughly 5-minute outpatient procedure.
The Bedford, Mass.-based women’s health products maker said U.S. physicians performed about 312,000 GEA procedures last year, about 205,000 using the NovaSure device, making Hologic’s market share roughly 66 percent.
The Food & Drug Administration gave the nod to Hologic Inc.‘s Adiana sterilization treatment, which uses a minimally invasive natural orifice surgical technique to provide permanent contraception.
The Bedford women’s health products maker said the the federal safety monitor gave pre-market approval for procedure, which involves threading an endoscope through the vagina, cervix and uterus into the fallopian tubes, where radiofrequency energy is applied to small sections of the tube.
