Faced with mounting legal costs related to its transvaginal mesh device, Boston Scientific (NYSE: BSX) (Marlborough, Mass.) slashed its full-year profit forecast for the second time this year. Boston Scientific cut its profit forecast by 4 cents to 28-34 cents a share on Thursday, but maintained its adjusted profit forecast.

The American Medical Association (Chicago) sparked a great deal of controversy in 2013 by officially recognizing obesity as a disease. That seemingly simple distinction may have played a significant part in attracting new device-based approaches for weight loss, making the market for such technology more competitive than ever. Medical Device Daily reported on the competitiveness of the space on Monday (Medical Device Daily, July 20, 2015) and this second part of that story explores the regulatory and reimbursement hurdles that have historically plagued the sector.

Competition in the bariatric device space continues as several new weight loss approaches have surfaced in the past two months and yet another may soon enter the U.S. market. Apollo Endosurgery (Austin, Texas) inherited both the Lap-Band and the Orbera intragastric balloon through its $110 million acquisition of Allergan's (Dublin, Ireland) obesity intervention division in 2013. The company reported pivotal trial results in May supporting the use of the Orbera balloon for weight loss and has submitted a premarket approval application, which is currently under FDA review. Apollo is a private, venture-backed company.