FDA Update: Ophthalmic Device Panel Meeting To Review LASIK Safety

LASIK Safety Review On April 25, 2008, the committee will discuss general issues concerning the experience and quality of life of patients who have had LASIK. How Serious is the Problem?  Are the Patients Going Blind? Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said a number of concerns have been […]

New FDA 510(k) Approvals for March 2008-(pt.1) New Video Monitor Screens

The FDA has published its 510(k) approval letters for March 2008. In terms of surgery, endoscopy, and imaging a few items caught my eye. The first is a pair of high resolution monitors from Eizo. Eizo is upgrading both monchrome and color workstations to 5-megapixel units. This will be useful for radiologic workstations. Here is […]

FDA Ob/Gyn Update: Panel Meeting to Review New Female Condom

I will be posting an ongoing series on FDA reviews and decisions on new devices focusing on minimally invasive surgery, future medical technologies, and Ob/Gyn devices.  What better way to start off the series then with the latest announcement of the FDA Gyn device review panel (Obstetrics and Gynecology Devices Panel of the Medical Devices […]