Company News
INVESTOR ANNOUNCEMENTS
PRESS RELEASE | December 7, 2023
BioPorto Receives FDA 510(k) Clearance for NGAL Test in the United States
ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker cleared for pediatric use (aged 3 months through 21 years) in the US and is designed to help doctors identify patients at risk of developing or having persistent, moderate-to-severe AKI. Read More
PRESS RELEASE | September 11, 2023
Update on NGAL Test Regulatory Pathway
Based on direction from the US Food and Drug Administration (FDA), BioPorto decided to change the regulatory pathway for the Company’s NGAL test from a De Novo to a 510(k). This is not expected to impact the FDA’s ongoing review process. Read More
PRESS RELEASE | November 10, 2022
FDA De Novo Submission with Breakthrough Device Designation
BioPorto submitted an FDA De Novo application with Breakthrough Device Designation for an NGAL test to aid in identifying pediatric patients ≥ 3 months to < 22 years at risk of moderate to severe acute kidney injury. Read More
PRESS RELEASE | June 20, 2022
BioPorto Appoints Dr. Prasad Devarajan as New Senior Medical Director
World-renowned pediatric nephrologist and NGAL expert Dr. Prasad Devarajan will join the BioPorto team effective July 1, 2022. CEO Tony Pare notes that “Dr. Devarajan’s unparalleled reputation, knowledge, and expertise will be a tremendous gain for BioPorto.” Read More