Key Highlights
- FDA Approval: Cleerly ISCHEMIA, an AI-based diagnostic software, has received U.S. FDA 510(k) clearance.
- Advanced Diagnostic Aid: Designed to assist healthcare providers in diagnosing heart disease using coronary computed tomography angiography (CCTA) analysis.
- Scientific Foundation: Built on over 20 years of research, including data from CREDENCE and PACIFIC trials.
Source: Business Wire
Notable Quote
- “We are pleased to have FDA 510(k) clearance for Cleerly ISCHEMIA and offer the software as part of Cleerly Labs to providers to support their diagnosis of patients across the entire heart disease continuum. Cleerly ISCHEMIA is a true testament to our unwavering commitment to scientific innovation and research-backed solutions – James K. Min, MD, FACC, FESC, MSCCT, Founder and CEO at Cleerly
SoH's Take
Cleerly’s latest achievement, the FDA-approved Cleerly ISCHEMIA, marks a significant milestone in the fight against heart disease. This innovative software embodies a major leap forward in precision medicine, leveraging the power of AI to transform the way coronary artery disease is diagnosed and managed. Cleerly’s commitment to scientific rigor and its dedication to enhancing diagnostic accuracy not only validates the promise of AI in healthcare but also sets a new bar for cardiac care standards. As healthcare professionals increasingly adopt such advanced tools, the potential for improved patient outcomes and personalized care becomes more tangible. Cleerly ISCHEMIA, thus, stands as a beacon of innovation in the ongoing quest to optimize heart health management.
