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FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths Instylla wins an expanded approval for arterial bleeds in vessels 6 mm or smaller CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Urologic Design raises $1.2M for a urethral occlusion device for men Sonocare Lab takes Bluepoint seed money for an ultrasound device that flushes brain waste Boston Scientific pushes its $14.5B Penumbra close into early 2027 FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn nerve stimulator alongside AF ablation FDA early alert covers every Medline brand bed after two deaths Instylla wins an expanded approval for arterial bleeds in vessels 6 mm or smaller CereVasc wins an IDE to test its endovascular CSF shunt in early Alzheimer's Urologic Design raises $1.2M for a urethral occlusion device for men Sonocare Lab takes Bluepoint seed money for an ultrasound device that flushes brain waste Boston Scientific pushes its $14.5B Penumbra close into early 2027

The Directory / Imaging & Radiology

Imaging & Radiology Neurology & Neurotech

Deep Reasoning AI

Sarasota, FL · Unknown · 510(k) cleared

Makes NeuroDR, software that runs after a head and neck CT angiography scan, strips bone, soft tissue and veins, and pushes 3D artery views of the carotid and vertebral arteries to PACS as DICOM images. Cleared by FDA in October 2026, co-developed with 3DR Labs.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Oct 7, 26	K262134510(k)	NeuroDR	Deep Reasoning Ai, Inc.	Radiology	QIH

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