WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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waste Boston Scientific pushes its $14.5B Penumbra close into early 2027 FDA renames its drug delivery performance draft guidance and sets a January 28 deadline FDA codifies four De Novo device types, including Samsung's sleep apnea feature StimCardio raises $30M to run a wrist-worn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

Imvaria

Berkeley, CA · Unknown · De Novo granted

Makes Fibresolve, software that reads lung CT scans to classify the diagnostic subtype of suspected interstitial lung disease and support assessment of idiopathic pulmonary fibrosis before invasive procedures. Authorized through De Novo in January 2024.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Nov 7, 25	K252041510(k)	Fibresolve (with PCCP)	Imvaria, Inc.	Radiology	QWO

← More Imaging & Radiology startups