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FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn nerve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waste Boston Scientific pushes its $14.5B Penumbra close into early 2027 FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn nerve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 / Neurology & Neurotech

Neurology & Neurotech Digital Health & SaMD

Paradromics

Austin, TX · Unknown · Breakthrough designation

Builds Connexus, a fully implanted intracortical brain-computer interface that records single-neuron activity across hundreds of channels and sends it wirelessly through intact skin.

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