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FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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waste Boston Scientific pushes its $14.5B Penumbra close into early 2027 FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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

IntuiTap Medical

Houston, TX · Unknown · De Novo granted

Built VerTouch, a handheld device that maps spinal anatomy at the bedside to guide needle placement for epidurals and spinal taps. Its De Novo authorization became the basis for a new FDA device type at 21 CFR 868.1985 in October 2026.

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