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Home » FDA nod for Hologic’s NovaSure buoys rival Conceptus | Regulatory Roundup

FDA nod for Hologic’s NovaSure buoys rival Conceptus | Regulatory Roundup

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Conceptus
Hologic

An FDA nod for Hologic (NSDQ:HOLX) will redound to the benefit of rival Conceptus (NSDQ:CPTS), making its Essure female sterilization device legally compatible with endometrial ablations systems made by Hologic, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX)

The federal watchdog agency approved labeling changes for Hologic’s NovaSure endometrial ablation system, which uses bipolar radio frequency to treat menorrhagia, or excessive menstrual bleeding.

Conceptus and Hologic are waging a bitter legal war over the Essure and Hologic’s competing Adiana system, with Conceptus looking to reinforce its $19 million win with a permanent injunction to keep Hologic’s Adiana device off the U.S. market.

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The FDA’s NovaSure decision means the Conceptus Essure procedure “is now approved to be safe and compatible with all the major global endometrial ablation technology options that treat menorrhagia,” according to a press release.

“Our competitive advantage and leadership in the permanent birth control market has been significantly strengthened by this upgraded label,” Conceptus CEO Keith Grossman said in prepared remarks. “We will be communicating the change to the OB/GYN community, and especially to those physicians who have used the competitor’s hysteroscopic sterilization product with NovaSure.”

MassDevice.com Regulatory Roundup

The MassDevice.com Regulatory Roundup

 Peanut allergy-fighting device gets on the fast track at the FDA

Bagneux, France-based DBV Technologies said it won today that it has received fast-track designation from the FDA for its Viaskin Peanut, which is designed to treat peanut allergy via epicutaneous immunotherapy. Read more

 Varian wins 510(k) for motion-tracking transponder

Varian Medical Systems (NYSE:VAR) received 510(k) clearance from the FDA for a surface beacon transponder for its Calypso system, “as a real-time tracking device capable of monitoring motion during radiotherapy treatments for indications anywhere in the body.” Read more

 Blue Belt Technologies wins CE Mark for handheld robotic surgical cutter

Blue Belt Technologies Inc. won CE Mark approval in the European Union for its Navio PFS System, a handheld robotic cutting device. Read more

 Koning wins CE Mark for breast CT system

Koning Corp. landed CE Mark approval for its Koning Breast CT cone beam computed tomography system. Read more

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