This is the first-ever designation for AI with such broad coverage of medical conditions under one solution. The FDA grants Breakthrough Device Designation to technologies that both significantly advance the diagnosis of severe diseases and represent an unmet clinical need. The designation is intended to accelerate access to life-saving innovations by expediting the review process. In this case, it enables parallel review of double-digit indications within a single submission, an important step toward bringing comprehensive, high–accuracy clinical AI to routine care while maintaining robust safety and effectiveness standards.

“With this designation and our ecosystem of specialized partners, we can deliver a broader set of solutions across many service lines. CARE’s ability to detect, characterize, measure, and compare findings underpins both current and in-development applications from triage to report drafting,” said Elad Walach, co-founder and CEO, Aidoc. “We are tackling this from multiple angles, developing innovations in parallel and, as each is FDA cleared, bringing it to market – delivering valuable, safe solutions while building toward the next milestone.”