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THE TAPE

FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation FDA clears Emboline's Emboliner, a TAVR filter tested head to head against Sentinel CraniUS clears a patient-specific cranial plate under K261058 Ropca clears its arthritis ultrasound robot for the US after four years in Europe Petal Surgical shows its histotripsy robot and says first-in-human is close FDA says it has never authorized a clear aligner sold without a prescription LUMA Vision clears a second VERAFEYE 510(k), adding catheter tracking and ablation marking FDA approves Abbott's TactiFlex Duo, one catheter that switches between pulsed field and RF Boston Scientific tells the SEC it will miss 2026 guidance after the August cyberattack Bioretec clears a headless bioabsorbable compression screw for hand and foot fixation

The Directory / Neurology & Neurotech

Neurology & Neurotech Drug Delivery & Infusion

CraniUS Therapeutics

Baltimore, MD · Series B · 510(k) cleared

Makes patient-specific cranial implants and is developing NeuroPASS, a skull-embedded platform for brain access, sensing and drug delivery.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 29, 26	K261058510(k)	CraniUS Plate	CraniUS, LLC	Neurology	GWO

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CraniUS Therapeutics

FDA DECISIONS ON FILE

COVERAGE