CE mark
Lucid Diagnostics Obtains CE Mark for Esophageal Cancer Molecular Test
Lucid said that key opinion leaders for esophageal disease in Europe are participating in pivotal clinical trials for the test and its collection device.
Roche Gets CE Mark for SARS-CoV-2 Antigen Self Test
An earlier version of the test has been available in some European markets under local special approval pathways since February.
Novacyt Gets CE Mark for Multigene SARS-CoV-2 Test, Launches RUO Variant Assay
The company has introduced a number of SARS-CoV-2 tests recently, including one for variants of concern and a high-throughput, extraction-free assay.
iXensor Gets CE-IVD Mark for Point-of-Care SARS-CoV-2 Antigen Test
The test runs on a palm-sized analyzer that provides results within 15 minutes, transmitting them to a companion smartphone app that stores vaccination data.
Lucid Diagnostics Gets CE Mark for Esophageal Cell Collection Device
The device is a swallowable balloon capsule catheter that allows physicians to sample surface cells from the esophagus in a noninvasive office procedure.
Apr 16, 2021