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THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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