Claros Diagnostics has announced the CE Mark approval for its rapid quantitative point-of-care diagnostic platform, which can now be used for prostate specific antigen (PSA) testing throughout the European Union. The approved system consists of a small portable analyzer and credit card-sized disposable. Claros is preparing for the European launch of its urology product and continuing the process to attain regulatory clearance in other markets, including the U.S.

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The American Urological Association (AUA)’s updated Prostate-Specific Antigen Best Practice Statement, first presented at the annual meeting of the AUA in April, was published in the November issue of the Journal of Urology. The statement includes the controversial guidance that the prostate-specific antigen (PSA) test should be offered to men starting at the age of 40 years, which one critic has said is not supported by any convincing evidence

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