Company News

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  |  March 15, 2023

Update From CEO Tony Pare

Preliminary 2022 financials, the status of US Food and Drug Administration (FDA) review, and a focus on European expansion.  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 28, 2022

BioPorto Achieves Targeted Enrollment in Clinical Study

This is the third part of a 3-part clinical study to support a US FDA De Novo submission for use of The NGAL Test in identifying patients under the age of 22 years at risk for acute kidney injury. Read More