Vax-Immune Diagnostics announces today it has received CE Mark approval for its first-in-class, medical device, LabReady® GBS. LabReady’s Group B Strep product is the first in Vax-Immune Diagnostics line up of women’s health solutions that helps avoid life-threatening complications and expensive consequences for mothers and their babies.
With CE Mark approval, LabReady is now available to European physicians, patients, and hospital systems.
The brainchild of Dr. Leonard E. Weisman, renowned neonatologist, LabReady aims to protect patients from the dangers and costs of misdiagnosis by giving physicians and microbiology labs a safer, smarter, and more economical way to treat patients’ sample.
“I have spent over 40 years watching newborns die or have developmental problems due to infections in the pregnant moms which could have been avoided. By using LabReady, infections can be detected prior to delivery, treated appropriately, thereby reducing infant mortality related to infection,” states Dr. Weisman.
Vax-Immune Diagnostics estimates the LabReady solution will be available in European markets as soon as Summer, 2021. LabReady will be available through provider channels, as well as in direct to consumer/home testing markets. Vax-Immune Diagnostics hopes to greatly decrease global infection mortality by making high-quality specimen collection accessible to everyone around the world.
About Vax-Immune Diagnostics and LabReady:
Vax-Immune Diagnostics, founded by Dr. Leonard E. Weisman, is a healthcare technology company that has built the world’s first and only full-integrated specimen enrichment transport system, LabReady, to help the medical community quickly and more accurately detect infectious diseases.