Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio Designed for short-term recordings up to 2.5hrs., the…

ByRidhi RastogiApril 3, 2026

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…

ByRidhi RastogiApril 17, 2025

Jay Pathmanathan, Medical Director at Beacon Biosignals Shares Insights on EEG Neurobiomarkers for the Development of Precision Medicines in Neurology

Shots: Jay spoke about the role of AI-based EEG neurobiomarkers in the development of therapies to treat neurologic diseases Jay also talked about the use of the EEG analytics platform for dose determination clinical research The interview gives an understanding of Beacon Biosignals' vision to accelerate new treatment options for neurological and psychiatric diseases Smriti: Throw…

BySenior EditorSeptember 27, 2022

Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Jay Pathmanathan, Medical Director at Beacon Biosignals Shares Insights on EEG Neurobiomarkers for the Development of Precision Medicines in Neurology

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