US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based maternal/fetal monitoring system. The company has also obtained CE Mark approval from the European Commission for its ...
LifeCodexx has revealed that its PrenaTest, a non-invasive molecular genetic blood test, can now be performed to determine high risk pregnancies even as early as the ninth week of pregnancy. Generally, PrenaTest is used to determine fetal ...
Tags: LifeCodexx, Pregnancy, Medicine
Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won't approve their devices for use, the FDA said. The FDA issued new ...
Verinata Health has introduced a non-invasive prenatal test to detect autosomal and fetal sex chromosome aneuploidies for high-risk pregnancies. The expanded indication of verifi prenatal blood test detects Turner syndrome(Monosomy ...
Tags: Verinata Health, non-invasive prenatal test, high-risk pregnancies