anemia
Sanguina Gains FDA 510(k) Clearance for Home-Use Hemoglobin Test
The firm's AnemoCheck Home is a disposable, prescription-use test to help patients with anemia due to nutritional deficiency, sickle cell disease, or thalassemia.
At-Home Testing Firm Sanguina Raises $2.8M in Series A Round
The company's sole commercialized product is an at-home test for determining total hemoglobin and calculated hematocrit in whole blood.
The firm has collaborated with Novartis to help pilot the new sickle cell disease test and a treatment in Ghana.
Agios Pharmaceuticals, PerkinElmer Partner on Hereditary Anemia Genetic Testing Program
The next-generation sequencing-based panel comprises more than 50 genes and disorders known to cause hereditary anemias, such as pyruvate kinase deficiency.
Siemens Healthineers, Hologic, DiaSorin, BioMérieux, Others Get FDA Clearances in May
Hologic received clearance for a change to a probe reagent in the Aptima Combo 2 assay to detect variants of Chlamydia trachomatis that have emerged recently.
Dec 4, 2019
Oct 6, 2017
Sep 6, 2017
FDA Clears Assays From CDC, Agilent, Abbott
Jun 23, 2017