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עברית

Aidoc Medical

Definition

Aidoc Medical is an Israeli company founded in 2016 that develops artificial intelligence for analyzing medical imaging (mainly CT) and detects urgent findings such as intracranial hemorrhage. It has received 18 FDA clearances so far, the highest number in clinical AI.

Four founders, one problem: time

Elad Walach, Michael Braginsky, Guy Reiner and Gal Yaniv founded Aidoc Medical in 2016 around a simple insight: in most hospitals, imaging scans wait in a queue in the order they arrive, not by how serious they are. A patient with an urgent brain bleed can wait behind less urgent routine scans, simply because they arrived later. The company's central idea was to use AI to scan every study as soon as it is done, and push forward in the queue any case in which the algorithm detects signs of a life-threatening finding, so that a radiologist reviews it within minutes rather than hours.

From ICH to 18 FDA clearances

The first FDA clearance Aidoc received, in 2018, dealt with a single finding: intracranial hemorrhage in brain CT scans. From there the company expanded gradually, with each additional FDA clearance covering a different urgent finding: pulmonary embolism (cleared in document K190072 from April 2019), large vessel occlusion stroke (January 2020), cervical spine fracture, intra-abdominal free air, and later also brain aneurysm. To date the company has accumulated 18 separate FDA clearances, each one an independent regulatory process that requires proof of clinical accuracy for a specific finding. According to reports, this number is higher than that of any other clinical AI company.

From $7 million to $520 million

Aidoc's funding path reflects the gradual maturing of the market for AI in medicine. The first round, $7 million in April 2017 led by TLV Partners, came at a stage when "AI for radiology" was still seen as a commercially unproven idea. The Series B, $27 million in April 2019 led by Square Peg Capital, came after the company had already shown its first FDA clearances. The real jump in scale came later: $150 million in July 2025 (a total of about $370 million), and another round in April 2026 that brought the total to about $520 million, a sign that investors now treat the field as mature rather than experimental.

From a single test to a whole platform

In the decade since its founding, Aidoc has moved from a single product (detecting intracranial hemorrhage) to a platform called aiOS, which runs an engine called CARE (Clinical AI Reasoning Engine) across dozens of findings at once in the same imaging study. This change matters because it solves an operational problem, not just a technical one: a hospital that wants to use several separate AI tools for several different findings has to integrate each of them separately with its imaging system, which is expensive integration work. A single platform that covers a wide range of findings, like aiOS, reduces this friction, and that is the main reason the company is investing in a broad "Breakthrough Device Designation" from the FDA.

A new regulatory designation: checking everything in one submission

In September 2025 Aidoc received an FDA "Breakthrough Device Designation" for a comprehensive triage solution for CT scans. According to the company, it is the first of its kind, allowing parallel review of dozens of different indications within one single regulatory submission, instead of submitting each finding separately as had been required until now. The meaning of the step: a faster approval path for a wide range of findings at once, instead of a process that takes years for each finding separately. If the process is completed successfully, it may also serve as a precedent for other clinical AI companies trying to widen the coverage of their products.

FAQ ❓

What exactly does Aidoc's software detect?

Urgent findings in imaging scans, mainly CT, such as intracranial hemorrhage, pulmonary embolism or stroke. It flags them for the radiologist so they are reviewed first.

Why do 18 FDA clearances matter?

Each clearance covers a specific urgent finding and requires separate proof of clinical accuracy. Eighteen clearances is the highest number recorded for a single clinical AI company.

How much money has Aidoc raised over the years?

From $7 million in its first round in 2017 to a total of about $520 million after a round in April 2026.

Does Aidoc replace radiologists?

No. The software changes the order of priority of the scans a radiologist reviews and flags suspicious findings, but the final diagnosis and the clinical decision stay with the doctor.

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