December 14, 2022 – Florence, Italy Baebies today announced it is expanding its partnership with medical device supplier Medical Horizons S.r.L to help bring newborn screening solutions to a greater …
Baebies Receives FDA 510(k) Clearance for G6PD Test on FINDER Platform
DURHAM, N.C. – (November 9, 2022) – Baebies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test …
SEEKER Newborn Screening Platform Now in Italy
Baebies Partners with Medical Horizons to Bring SEEKER Newborn Screening Platform to Italy Meyer Children’s Hospital in Florence becomes first screening location FLORENCE, Italy, May 10, 2022 – Baebies®, a …
Baebies Earns CE Mark for FINDER SARS-CoV-2 Testing Platform
DURHAM, N.C. – (March 24, 2022) – Baebies® announced today it has received CE Mark for its FINDER® SARS-CoV-2 point-of-care test, which performs RT-PCR testing to detect SARS-CoV-2 on the …
Baebies Awarded $2.7 Million NIH Grant for Rapid, Near-patient Heparin Monitoring Requiring Low Sample Volume
Baebies was recently awarded $2.7 million in a Phase IIB SBIR grant from the National Institutes of Health (NIH). This award supports validation, clinical evaluation, and FDA submission of a rapid test panel for near-patient heparin monitoring. This project is a continuation of a long-standing collaboration with Boston Children’s Hospital.
Baebies Awarded up to $11.6 Million from CARB-X for the Development of a Diagnostic Platform with Rapid Results for Sepsis
Baebies announced today that CARB-X has awarded the company up to $11.6 million in non-dilutive funding. This funding will support the development of a near-patient and rapid diagnostic platform for sepsis – specially focused on addressing the unique needs of neonatal and pediatric populations.
Baebies Announces FDA Acknowledgement of Emergency Use Notification for FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test
RT-PCR within 17 minutes. Baebies announces FDA acknowledgement of Emergency Use Notification (EUN) for an RT-PCR test to detect SARS-CoV-2 on the FINDER 1.5 Instrument.
Baebies Reaches Milestone of 10 Million Newborn Screening Tests Delivered
Baebies has delivered 10 million tests to newborn screening labs around the world since the company was founded. This milestone translates to 10 million chances to provide a healthy start. Learn more about Baebies mission and growth.
Baebies Wins the 2020 AACC Disruptive Technology Award
Baebies was selected as the winner of the AACC Disruptive Technology Award by a panel of expert judges at the #2020AACC Annual Meeting. During the virtual competition, Baebies presented FINDER®, a diagnostic platform featuring a toaster-sized instrument and disposable cartridge.
Baebies Selected as Finalist for the 2020 AACC Disruptive Technology Award
Baebies has been named a finalist for the 2020 American Association for Clinical Chemistry’s (AACC) Disruptive Technology Award for FINDER®, a near-patient testing platform. As a growth-stage company developing diagnostic products to provide a healthy start for children everywhere, Baebies FINDER tests for diseases from low blood volume (50 µL) with a turn-around time of approximately 15 minutes after sample introduction.