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 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.
Interlace Medical Inc. won 510(k) clearance from the Food & Drug Administration for its MyoSure fibroid removal system.
The Framingham, Mass.-based gynecological device maker said its hysteroscopic tissue removal system is a minimally invasive technique that allows for the removal of submucosal fibroids and polyps in a single, out-patient procedure. Submucosal fibroids are benign tumors that grow just beneath the endometrial lining of the uterus.
BioSphere Medical Inc. is touting study published in the Journal of Vascular Interventional Radiology indicating that uterine artery embolization compares favorably to laparoscopic occlusion of uterine arteries in the treatment of uterine fibroids.
The Rockland, Mass.-based firm said the study of 58 women with uterine fibroids (or leiomyomas) showed that the rate of recurrence for patients who underwent the UAE procedure was “significantly lower” than in patients who received laparoscopic treatment.
Mpathy Medical is touting the results of a small study of its Omnisure sling for treating female stress urinary incontinence.
The Glasgow, Scotland based company, which has its U.S. headquarters in Raynham, Mass., said the 61-patient trial showed a 92.4 percent cure rate, defined as patients who were reported as “dry” after implantation.
Solace Therapeutics capped a big week with a win at the MassMEDIC 11th Annual Medtech Investors Conference, landing the first MedTech Ignite 10k Innovative Technology Competition award.
The Framingham, Mass.-based medical device maker won CE Mark approval in the European Union Oct. 1 for its intravesical system to treat female stress urinary incontinence.
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.