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Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

The Directory / Neurology & Neurotech

Ceribell

Sunnyvale, CA · Public · 510(k) cleared

Point-of-care EEG for acute care. A disposable headband and portable recorder pair with seizure detection and quantitative trending software so bedside staff can start a study without a technologist.

FDA DECISIONS ON FILE

8 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 16, 26	K261712510(k)	Ceribell EEG Analysis Software	Ceribell, Inc.	Neurology	OLT
Jun 30, 26	K261101510(k)	Ceribell Monitor	Ceribell, Inc.	Neurology	OMC
Jun 24, 26	K260998510(k)	Ceribell Neurology Review Software	Ceribell, Inc.	Neurology	OMB
Apr 3, 26	K260363510(k)	Ceribell Brain Monitor Headband	Ceribell, Inc.	Neurology	GXY
Feb 9, 26	K254033510(k)	Ceribell Instant EEG Headset	Ceribell, Inc.	Neurology	GXY
Dec 8, 25	K251936510(k)	Ceribell Delirium Monitor System	Ceribell, Inc.	Neurology	NCG
Nov 21, 25	K252070510(k)	Ceribell Infant Seizure Detection Software	Ceribell, Inc.	Neurology	OMB
Oct 31, 25	K251381510(k)	Ceribell Instant EEG Headcap (Small: C251, Medium: C252)	Ceribell, Inc.	Neurology	GXY

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Ceribell

FDA DECISIONS ON FILE

COVERAGE