Healio

FDA grants 510(k) clearance to AI-powered delirium screening device

The FDA has granted 510(k) clearance to a Bay Area medical technology firm for its proprietary delirium monitoring solution, the first and only such device to receive FDA clearance, according to the ...
Investing

FDA clears Ceribell’s delirium monitoring system for ICU patients

SUNNYVALE, Calif. - Ceribell, Inc. (NASDAQ:CBLL) has received 510(k) clearance from the U.S. Food and Drug Administration for its delirium monitoring solution, according to a company press release ...
Nasdaq

Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution

Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoring SUNNYVALE, Calif., Dec. 09, ...
Nasdaq

CBLL Gets FDA Consent for One-of-a-Kind Delirium Monitoring Solution

CeriBell Inc. CBLL recently announced that the FDA has given 510(k) clearance for its latest delirium monitoring solution, making it the one and only FDA-cleared solution for continuous tracking of ...
Mena FN

Ceribell Receives FDA 510(K) Clearance For First-Of-Its-Kind Delirium Monitoring Solution

(MENAFN- GlobeNewsWire - Nasdaq) Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium ...
Business Insider

Ceribell Receives FDA 510(k) Clearance for First-of-its-Kind Delirium Monitoring Solution

SUNNYVALE, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with ...

Medical Breakthroughs: 5 AI Innovators Redefining What's Possible

MarketsandMarkets forecasts the sector will expand at 38.6% annually through 2030 [3], driven by chronic disease burden and data explosion. The FDA cleared over 1,250 AI-enabled medical devices by mid ...