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Efferon NEO Receives CE Mark for Pediatric Sepsis Treatment

Efferon NEO Receives CE Mark for Pediatric Sepsis Treatment

First seen 11 Oct 2026, 16:34 UTC • •
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ThreatCluster AI
ThreatCluster •October 12, 2026 at 16:34 UTC
  • •Efferon NEO is the first CE-marked device for pediatric sepsis treatment in Europe.
  • •The device effectively removes endotoxins and cytokines from the bloodstream.
  • •Efferon NEO is currently used in 30 countries and aims for FDA approval.

Efferon, a biotech company, has received the CE MDR mark for Efferon NEO, the first multimodal extracorporeal blood purification device specifically designed for pediatric patients suffering from sepsis and septic shock. This certification is based on the results of the multicenter LASSO NEO study, which demonstrated the device's clinical efficacy in removing endotoxins and inflammatory mediators from the bloodstream of children aged 1 month to 18 years. Efferon NEO is now being utilized in intensive care units across 30 countries, including hospitals in Europe, Saudi Arabia, and Thailand. The device is engineered to cater to the unique physiological needs of children, who have different blood volumes and responses compared to adults. Efferon aims to improve recovery rates and reduce organ failure in critically ill pediatric patients. The company is also preparing to file for FDA approval in the United States.

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Timeline

2026-04-22
Efferon NEO receives CE MDR mark
Efferon announced the CE MDR certification for Efferon NEO, marking it as Europe's first device for pediatric sepsis treatment.
markets.businessinsider.com
2026-10-11
Efferon NEO highlighted at TechCrunch Disrupt
Efferon was featured at TechCrunch Disrupt 2026, showcasing its mission to reduce pediatric sepsis mortality.
Techcrunch

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Common questions

What is Efferon NEO?
Efferon NEO is a multimodal blood purification device designed specifically for pediatric patients with sepsis.
What does the CE MDR mark signify?
The CE MDR mark indicates that Efferon NEO meets European safety and efficacy standards for medical devices.
Where is Efferon NEO currently used?
Efferon NEO is used in intensive care units across 30 countries, including Europe, Saudi Arabia, and Thailand.