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BioSphere Benefits From Broader UFE Awareness, But Remains Short On Profit

This article was originally published in The Gray Sheet

Executive Summary

Uterine fibroid embolic device maker BioSphere Medical credits Q4 revenue growth to a series of favorable technology assessments, improved marketing management and a high-profile procedure

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People In Brief

American Medical Systems: Martin Emerson assumes Minnetonka, Minn. firm's president & CEO spot effective Jan. 5, replacing Douglas Kohrs, who will remain chairman of AMS' board. A 20-year device industry veteran, Emerson has spent his last four years at American Medical Systems in various executive roles, including VP-general manager of international, exec VP-global sales & marketing and chief operating officer. His previous career experience includes stints at Baxter International and Boston Scientific. Currently, AMS is preparing a PMA supplement for its TherMatrx TMx-2000 BPH thermotherapy system (1"The Gray Sheet" Nov. 8, 2004, p. 6)...

InSightec ExAblate 2000 Approved For Uterine Fibroids; 3-Year Study Required

FDA approval conditions for InSightec's ExAblate 2000 uterine fibroid ultrasound treatment respond to advisory panel concerns about short-term safety and efficacy data in the original PMA submission

Biocompatibles’ Drug-Eluting UFE Treatment Would Be Marketed By Terumo

Biocompatibles International may await development of a drug-eluting version of its Bead Block microspheres therapy before seeking FDA clearance for uterine fibroid embolization (UFE)

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