Harrison.ai Reinvents CT Imaging AI with Three FDA Breakthrough Designations
Harrison.ai, a global pioneer in clinical artificial intelligence, has announced a significant milestone: the company now holds three FDA Breakthrough Device Designations for its innovative CT imaging solutions. This achievement underscores Harrison.ai’s leadership in advancing next-generation AI technologies designed to enhance the efficiency and quality of patient care worldwide.
At the core of these groundbreaking advancements are comprehensive AI models, meticulously trained on one of the largest annotated radiology datasets in existence. The dataset comprises over one million clinical studies and 550 million expert-labelled findings, developed and validated with input from more than 140 board-certified radiologists. These deep learning models not only power Harrison.ai’s cutting-edge solutions but also lay the foundation for auto-generated draft reporting tools currently in development. By leveraging this robust data infrastructure, Harrison.ai is redefining how AI can streamline workflows and improve diagnostic accuracy for healthcare providers.
Leading the Charge in U.S. Healthcare Innovation
Among Harrison.ai’s notable achievements is its Comprehensive Care – Obstructive Hydrocephalus triage and prioritization solution. This solution stands out as one of only 13% of FDA Breakthrough Devices to have received marketing authorization, such as 510(k) clearance. Even more impressively, it is one of just two radiology-focused FDA Breakthrough Devices to qualify for Medicare’s New Technology Add-on Payment (NTAP).
The NTAP designation is a testament to the solution’s ability to deliver substantial clinical improvements over existing services, aligning with the rigorous standards of the FDA Breakthrough Device program. This eligibility accelerates U.S. hospital access to the technology while ensuring reimbursement, thereby facilitating broader adoption and integration into real-world healthcare settings. For healthcare systems grappling with the challenges of timely diagnosis and treatment, this breakthrough solution offers a lifeline, enabling faster and more accurate identification of critical conditions like obstructive hydrocephalus.
A Global Footprint of Clinical Trust and Impact
Harrison.ai’s influence extends far beyond the United States. The company’s clinical and workflow solutions are currently deployed across more than 1,000 customer sites spanning the USA, Europe, Asia, and Australia. This widespread adoption highlights Harrison.ai’s reputation for delivering clinically validated AI tools that make a tangible difference in patient outcomes.
By addressing some of the most pressing challenges in medical imaging—such as reducing diagnostic delays, improving workflow efficiency, and enhancing diagnostic accuracy—Harrison.ai has earned the trust of healthcare providers worldwide. Its solutions are not just technological innovations but practical tools that empower clinicians to focus on what matters most: delivering high-quality patient care.
Partnering to Drive AI Adoption in Healthcare
“We’re proud to collaborate with leading U.S. health systems and private practices that share our vision of integrating advanced AI technology into patient care,” said Dimitry Tran, co-founder of Harrison.ai. “Our partners have expressed strong appreciation for the fact that Comprehensive Care – Obstructive Hydrocephalus is eligible for NTAP, recognizing it as a pivotal step toward bringing clinically proven AI solutions into everyday practice.”
This sentiment reflects Harrison.ai’s commitment to fostering partnerships that bridge the gap between innovation and implementation. By working closely with healthcare providers, the company ensures that its solutions are not only technologically advanced but also aligned with the practical needs of clinicians and patients alike. Such collaborations are instrumental in driving the adoption of AI-driven tools that enhance both operational efficiency and clinical outcomes.
Transforming Radiology Through AI-Driven Insights
The potential of AI in radiology is vast, and Harrison.ai is at the forefront of unlocking this potential. By combining deep learning models with an unparalleled dataset, the company is setting new standards for precision and reliability in medical imaging. Its auto-created draft reporting feature, currently under development, exemplifies how AI can reduce administrative burdens for radiologists, allowing them to dedicate more time to patient care.
Moreover, the company’s emphasis on regulatory compliance and clinical validation ensures that its solutions meet the highest standards of safety and efficacy. This approach not only builds trust among healthcare providers but also paves the way for broader acceptance and integration of AI technologies in clinical practice.
Pioneering the Future of Patient-Centric Care
Harrison.ai’s three FDA Breakthrough Designations mark a significant leap forward in the evolution of AI-powered CT imaging. By addressing critical gaps in diagnostic workflows and prioritizing patient outcomes, the company is transforming the landscape of modern healthcare. Its solutions exemplify how AI can be harnessed to tackle real-world challenges, from triaging life-threatening conditions to streamlining radiology workflows.
As Harrison.ai continues to expand its global footprint and deepen its partnerships, the company remains steadfast in its mission to drive meaningful change in patient care. With its innovative technologies and unwavering commitment to excellence, Harrison.ai is poised to lead the charge in revolutionizing healthcare through AI.
Join the Revolution in Medical Imaging
Harrison.ai’s achievements underscore the transformative power of AI in radiology and beyond. By earning three FDA Breakthrough Designations and securing NTAP eligibility for its Comprehensive Care – Obstructive Hydrocephalus solution, the company has demonstrated its ability to deliver impactful, clinically validated innovations. As healthcare providers around the world embrace these advancements, Harrison.ai is proving that AI is not just a tool—it’s a catalyst for better, faster, and more equitable patient care.
For healthcare systems seeking to integrate cutting-edge AI into their operations, Harrison.ai offers a proven pathway to success. With its unmatched expertise, robust dataset, and dedication to clinical excellence, the company is shaping the future of medical imaging—one breakthrough at a time.
About Harrison.ai
Harrison.ai is a global healthcare technology company enhancing clinician capacity and patient care through AI automation. Clinician-led and patient-first, our suite of solutions supports earlier, more accurate diagnoses and seamlessly integrate into clinical workflows. Harrison.ai solutions are available in 40+ countries and to half of all Australian radiologists. They are clinically deployed at 1,000+ customer sites globally, including 40+ NHS Trusts and all public emergency departments in Hong Kong. With 3,400+ clinicians using our tools, Harrison.ai has impacted 6.7 million patients’ lives to date.
