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Urinary Incontinence: Mesh Slings Come Under Fire

Executive Summary

A large, undertreated patient population makes the urinary incontinence market an attractive arena for manufacturers; however, looming changes to the product approval process have added a level of uncertainty about future market growth.

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Medical Device Market & Industry Briefs, June/July 2012

Brief summaries of recent medtech market and industry developments. This month we cover recent developments in renal denervation, which may be the next blockbuster device market, MindRay’s acquisition of China’s Wuhan Dragonbio Surgical Implant Co., and the GAO’s report on implantable device use by Medicare beneficiaries.

Women's Health: Promising Advances, But Challenges Persist

The field of women's health is one of the most progressive medical technology sectors in the US, driven by the aging population, diagnostic advances in deadly ovarian and colorectal cancer, and medical device innovations in gynecologic and urogynecologic disease management, including a shift toward minimally invasive surgery (MIS) techniques and robotics and the addition of a new field: bariatric gynecology. At the WH 2.0 Consensus Conference on Women's Health, held recently in Los Angeles, experts agreed that advances in medical technology are promising better detection and treatment of a host of diseases impacting both premenopausal and postmenopausal women. However, challenges remain in managing obesity-related disease and improving screening for often-undetected cancers in women.

FDA Panel: Transvaginal Mesh For Prolapse Should Be Class III

Current and future surgical mesh devices for pelvic organ prolapse repair would require PMA submissions under a recommendation last week by FDA’s Obstetrics and Gynecology Devices panel.

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