The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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.
Cordis Corp. and a co-defendant appealed a jury verdict awarding Spectralytics Inc. $22.5 million in a laser stent-cutting patent infringement suit.
Cordis and Norman Noble Inc. filed the appeal in the U.S. Court of Appeals for the Federal Circuit. Spectralytics had sued the pair in July 2005 in the U.S. District Court for Minnesota, alleging infringement of a patent for a “Laser Cutting Tool for Cutting Elongated Hollow Workpieces.”
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Philips issued a voluntary recall of about 5,400 of its HeartStart FR2+ automated external defibrillators after discovering a microchip failure that “may render the device inoperable.”
The Dutch conglomerate said no adverse events have been reported in connection with the recall.
It affects only a few HeartStart FR2+ models made between May 2007 and Jan. 2008. The potential problem was detected via routine self-diagnostic tests, not during emergency use, the company said.
The BIO International Convention is on its way back to Boston, five years after its last visit to the Hub set all-time attendance records.
The conference attracted a record 22,366 visitors back in 2007, but attendance since then has dragged significantly, falling to 20,108 in San Diego in 2008 and to 14,352 this year in Atlanta, according to a BIO International spokesperson.
Thermoplastic film and sheet maker Argotec Inc. opened a new, 95,000-square-foot headquarters and manufacturing plant in its home base of Greenfield, Mass.
President and CEO Bruce Wilby said (PDF) the new digs, which take its total manufacturing operation to more than 150,000 square feet, allows it to expand its footprint into new products and markets.
Argotec makes custom-engineered urethane film and sheet for the medical, textile lamination, automotive, glass and graphics markets.
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.
Insulet Corp. amended its $60 million credit facility with Deerfield Management in a move it says will save $12 million.
The original deal, inked in March, called for the Bedford, Mass.-based insulin management system maker to borrow $27.5 million, with another $32.5 million available at Insulet’s discretion.
The Food & Drug Administration admitted to undue influence from four congressmen and former commissioner Andrew von Eschenbach in its approval of ReGen Biologics’ Menaflex knee implant despite opposition from FDA scientists, according to news reports.
Richard Packer probably doesn’t get confused for Konosuke Matsushita very often (first off, Packer’s a lot taller), but listening to the CEO of Zoll Medical Corp. speak about his vision for the company can conjure images of the legendary founder of Panasonic and his 250-year business plan.
Recently we were presenting brand strategy to a large client group and the topic turned to viral marketing. We stated that the goal of such techniques as social media was to generate word of mouth, which, as any marketer knows, can be the best kind of advertising. It seemed a given and I was ready to move on to the next point.
Suddenly, one listener, a young woman in the company’s e-marketing department, raised her hand.
“I don’t mean to be thick,” she said. “But exactly what do we mean when we say ‘word of mouth’?”
