WHERE ARE YOU?

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

THE TAPE

adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans adsilico raises 10 million pounds to test implants on virtual patients X9 wins a Breakthrough designation for power-assisted dialysis cannulation Smith+Nephew and J&J ortho merger talks collapse over who would run it Rivanna clears a machine learning bone overlay for its Accuro XV ultrasound Teleflex takes a Breakthrough designation for its resorbable magnesium scaffold in PCI Edwards wins FDA approval for Pascal Precision in tricuspid repair EQT agrees to take Qiagen private for 10.8 billion euros Elucid clears FFR-IQ under K262015 and folds plaque biology into FFR-CT Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans

The Directory / Imaging & Radiology

Coreline Soft

Seoul, South Korea · Public · 510(k) cleared

Korean maker of the AVIEW chest CT analysis suite, covering lung nodule detection, coronary artery calcium scoring and automated aortic measurement.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Oct 16, 26	K260391510(k)	AVIEW Aorta Metrics	Coreline Soft Co., Ltd.	Radiology	JAK
Dec 3, 25	K251203510(k)	AVIEW Lung Nodule CAD	Coreline Soft Co., Ltd.	Radiology	OEB

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