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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Directory / Imaging & Radiology

Imaging & Radiology Digital Health & SaMD

Aidoc

Tel Aviv, Israel · Series D+ · 510(k) cleared

Sells FDA-cleared AI triage and quantification software for CT and X-ray through its aiOS platform, now built on the CARE foundation model. More than 30 510(k) clearances since 2018.

FDA DECISIONS ON FILE

5 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
May 14, 26	K261317510(k)	BriefCase-Triage	Aidoc Medical , Ltd.	Radiology	QAS
Feb 26, 26	K253578510(k)	BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device	Aidoc Medical , Ltd.	Radiology	QAS
Jan 27, 26	K251195510(k)	BriefCase-Triage	Aidoc Medical , Ltd.	Radiology	QAS
Jan 7, 26	K252970510(k)	BriefCase-Triage: CARE Multi-triage CT Body	Aidoc Medical , Ltd.	Radiology	QAS
Nov 6, 25	K253265510(k)	BriefCase-Triage	Aidoc Medical , Ltd.	Radiology	QAS

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Aidoc

FDA DECISIONS ON FILE

COVERAGE