FDAnews Device Daily Bulletin

Claims made in marketing materials for Bausch + Lomb contact lenses have landed the Rochester, N.Y., company an FDA warning letter.

An FDA inspection of Salt Lake City-based BioMeridian International resulted in 16 observations, most relating to missing procedures or documentation.

Delegates at the 19th International Aids conference in Washington, DC, in the United States this week were convinced the world was on the cusp of a major advance against HIV and that a medical device, known as the PrePex, could help 14 African countries, including South Africa, to speed up male circumcision to achieve a goal of circumcising 80 percent of men between the ages of 15 and 49 by 2015.

Medical device wholesalers are increasing their “generic” offerings, a trend that may pose new problems for an industry already under pricing pressure.

A terrible scourge in the developing world, anemia claims hundreds of thousands of lives every year. Medical tests to detect the condition and prevent tragedy are often unavailable, but students at John Hopkins University have invented a sensor that turns a cell phone into an inexpensive blood analysis tool.

BioMed Diagnostics announced its patented InTray and InPouch product lines will now be available worldwide through a new agreement with VWR International.

Cook Medical has begun making available its Aprima Access Nonvascular Introducer Set that’s indicated for use when placing wire guides during interventional radiology procedures with single-puncture percutaneous access.

A California couple has been awarded $5.5 million in a lawsuit against the medical device manufacturer C.R. Bard, makers of the vaginal mesh implant that caused plaintiff Christine Scott to develop incontinence, chronic pain and sexual dysfunction.