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THE TAPE

Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape FDA codifies eight De Novo device types as Class II, three years after granting them Precera Medical buys Additive Metal Services to bring metal injection molding in house Powerful Medical wins a De Novo for AI that flags heart attacks on a 10-second ECG Zenflow says four US centers have run the first commercial Spring cases FDA says it has never authorized a clear aligner sold without a prescription CraniUS clears a patient-specific cranial plate under K261058 FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel Petal Surgical shows its histotripsy robot and says first-in-human is close Axogen to pay $200M cash for BioCircuit and its sutureless NerveTape FDA codifies eight De Novo device types as Class II, three years after granting them Precera Medical buys Additive Metal Services to bring metal injection molding in house Powerful Medical wins a De Novo for AI that flags heart attacks on a 10-second ECG Zenflow says four US centers have run the first commercial Spring cases FDA says it has never authorized a clear aligner sold without a prescription CraniUS clears a patient-specific cranial plate under K261058 FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel Petal Surgical shows its histotripsy robot and says first-in-human is close

The Directory / Neurology & Neurotech

Neurology & Neurotech Wearables & Remote Monitoring

Naox Technologies

Paris, France · Seed · 510(k) cleared

Builds an earbud-based EEG system that records single-channel brain activity at home and sends it to clinicians. Cleared in the US in January 2026.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Nov 25, 25	K251550510(k)	NX01 (NX01)	Naox Technologies Sas	Neurology	OMC

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