Global BioClinical

HHS Delays Common Rule for Another Six Months June 19, 2018 Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced it is delaying, again, rollout of the revised Common Rule on the protection of human subjects in clinical trials for six months—until January 21, 2019. HHS is also granting an exception from the existing federal policy for three burden-reducing provisions during the delay period. [ 320 more words ]

HHS Delays Common Rule for Another Six Months HHS Delays Common Rule for Another Six Months June 19, 2018 Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced i…

UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%. Amsterdam, the Netherlands; San Diego, CA, USA; and Holzgerlingen, Germany; April 19, 2018, 01:00 EDT -- Curetis N.V. (the "Company" and, together with Curetis USA Inc. and Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the successful completion of clinical performance evaluation and CE-IVD marking of its novel Unyvero Application Cartridge, UTI, for the diagnosis of severe urinary tract infections. [ 1,068 more word ]

Curetis Launches CE-IVD Marked Unyvero Urinary Tract Infection (UTI) Cartridge UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%. Amsterdam, th…

- First ever multiplex MDx test to be granted clearance by the FDA for this indication - Commercial launch in the U.S. expected this quarter Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, April 03, 2018, 15:45 am EDT - Curetis N.V. (the "Company" and, together with Curetis USA Inc. and Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, announced today that the Company has been granted a De Novo clearance by the U.S. [ 1,296 more word ]

Curetis Receives U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge – First ever multiplex MDx test to be granted clearance by the FDA for this indication – Commercial launch in the U.S. expected this quarter Amsterdam, the Netherlands, San Diego, CA, U…