Ceribell received breakthrough device designation for its LVO stroke detection monitor, and Naox Technologies secured 510(k) clearance for its in-ear EEG device.
Naox Technologies SAS secured U.S. FDA 510(k) clearance for Naox Link, its in-ear electroencephalography (EEG) device for clinical use both at home and in health care settings. Naox Link is a pair of ...
The company will use the money to try to establish its cuffless device as a go-to option for 24-hour blood pressure ...
Inspira Technologies Oxy BHN ( ($IINN) ) has issued an announcement. On January 5, 2026, Inspira Technologies Oxy B.H.N. Ltd. signed a non-binding ...
BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) ...
CV seeks FDA clearance to add AI-based reading to CapsoCam Plus to boost diagnostic accuracy and streamline reviews.
KORU Medical filed a 510(k) to use FreedomEDGE for subcutaneous PHESGO delivery, expanding into oncology and simplifying ...
CapsoVision, Inc. ( ($CV) ) has shared an announcement. On December 29, 2025, CapsoVision, Inc. announced it had submitted a 510(k) application to ...
HeartSciences Inc. (Nasdaq: HSCS) ("HeartSciences" or the "Company"), a healthcare information technology ("HIT") company focused on advancing electrocardiography ...
NEW YORK - The US Food and Drug Administration granted 510(k) marketing clearances in November to Roche Molecular Systems, Cytovale, Truvian Health, and others for infectious disease pathogen ...
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