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FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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waste Boston Scientific pushes its $14.5B Penumbra close into early 2027 FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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

Respiratory & Sleep Wearables & Remote Monitoring

Acurable

London, UK · Unknown · 510(k) cleared

Makes AcuPebble, a wearable acoustic sensor worn on the neck that records breathing and heart sounds at home to diagnose sleep apnea.

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