Home-based kit provides complete semen evaluation
Researchers from Florida Atlantic University’s College of Engineering and Computer Science are developing a home-based kit that they say accurately, quantitatively, and quickly provides a complete semen evaluation using microfluidics, an app, and a smartphone. The user-friendly sperm kit will cost less than $2 per kit to develop and will require one drop of fluid. The kit is being developed to be compatible with all smartphone models. It will consist of a sperm scope, a lens that functions like a microscope that snaps onto the phone, and a microfluidic chamber that will be able to analyze semen at the “micron” scale. Using the app, which will be included in the kit, technology developed at Florida Atlantic will capture, record, and analyze important details about the user’s semen. Easy-to-read results will be available in about 1 minute to inform the user whether he needs to seek further medical attention.
FDA: Topical ED cream NDA not approvable in present form
The FDA has issued a complete response letter for the new drug application (NDA) of alprostadil, DDAIP.HCl (Vitaros), a topical cream for the treatment of erectile dysfunction. The letter indicates that the FDA cannot approve the NDA in its present form, identifying deficiencies related to Chemistry, Manufacturing, and Control and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. Apricus Biosciences, Inc., the agent’s developer, said it is assessing the content of the letter with regulatory experts, including information that may be needed to resolve the deficiencies and the time it would take to obtain such information.
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