MeMed has received the breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its MeMed Severity test.
MeMed Severity is intended for managing patients with suspected sepsis and acute infections.
According to Israel-based MeMed, the investigational test helps clinicians make faster, data-driven decisions with clinical insights. It helps clinicians rapidly stratify risk and predict sepsis disease progression.
The test builds on the success of the FDA-cleared MeMed BV test, which helps differentiate bacterial and viral infections.
MeMed Severity also complements clinical evaluations and other laboratory findings.
The test uses advanced host-response technology to analyse blood proteins and apply machine learning for risk stratification in patients with suspected acute infections, predicting deterioration to severe outcomes within 72 hours or the likelihood of death within 14 days.
Designed for emergency department settings, it aids critical decisions on triage, treatment, and optimised patient disposition, helping clinicians identify those who could benefit from escalated care or safe discharge.
MeMed Severity is said to deliver easy-to-interpret results in under 15 minutes, with minimal blood volume requirements and compatibility with high-throughput analysers.
Its integration into clinical workflows enhances efficiency for both care providers and patients.
The FDA’s breakthrough device designation will fast-track MeMed Severity’s market path, support its reimbursement strategies, and ensure rapid availability to healthcare providers.
MeMed CEO and co-founder Eran Eden said: “The FDA’s BDD for MeMed Severity validates our commitment to addressing critical healthcare challenges with novel host-response technologies.
“We are grateful for the FDA’s commitment to collaborate with MeMed during its rigorous development process to create a test capable of filling a critical gap in sepsis management, equipping clinicians with valuable insights to improve care and save lives.”
MeMed aims to simplify the immune system’s complex signals into clear insights and advance disease diagnosis and treatment.
The biotech company uses its host-response profiling and machine learning expertise to develop a portfolio of tests for challenging clinical dilemmas.
In July 2023, MeMed secured FDA clearance for the use of the MeMed BV test on whole blood samples on the point-of-need MeMed Key analyser.
In May this year, the Israeli firm extended its partnership with Beckman Coulter Diagnostics to distribute its products in the US and Europe.
