Cupertino, California - 30th May 2024 – CARPL.ai has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its cutting-edge enterprise imaging AI platform. This milestone reaffirms CARPL’s commitment to safely transforming radiology with advanced AI and automation that streamlines clinical workflows and improves patient outcomes.
The clearance includes CARPL’s universal AI viewer which allows radiologists to utilize multiple AI applications through a single user interface. CARPL’s viewer can be integrated into any major PACS vendor. The announcement makes CARPL a unique AI platform with FDA clearance, and the only dedicated AI marketplace to have such clearance.
CARPL is the world’s first end-to-end AI platform that enables healthcare providers to build, discover, test, deploy, and monitor radiology AI applications. Featuring over 110 AI applications from 50+ vendors, CARPL’s comprehensive AI marketplace is utilized by leading healthcare institutions globally, including Massachusetts General Hospital, University Hospitals in Cleveland, I-MED Radiology in Australia, and the Singapore Government Healthcare System, among others.
The CARPL platform securely integrates AI into radiologist workflows, supporting various use cases such as exam prioritization, report auto-population, clinical audits, abnormality detection, segmentation, quantification, and characterization. Its universal AI viewer, integrated natively with a healthcare provider’s PACS, provides radiologists with a unified experience by eliminating the need to navigate multiple user interfaces.
"By prioritizing a secure development framework from the very beginning, CARPL has achieved a critical milestone ensuring that patient safety remains at the forefront of AI deployment in radiology," said Vidur Mahajan, Chief Executive Officer at CARPL.ai. "This FDA clearance opens the door for widespread adoption of AI solutions through a platform approach which simplifies the process of selection, implementation, and procurement of AI by health systems."
“CARPL.ai’s FDA clearance will now allow AI applications that have FDA approval but do not have their own FDA-cleared viewers to get integrated into PACS, enabling complex workflows such as accept/reject/modify AI outputs and turning AI outputs on and off,” said Dr. Vijay Rao, Professor of Radiology and Senior Vice President of Enterprise Imaging at Jefferson Health, who is a clinical advisor to CARPL.ai. “Keeping the human in the loop is most critical since running AI safely is paramount in clinical situations. CARPL’s universal AI viewer enables this,” she added.
CARPL.ai’s flexible platform can be hosted on-premise, on private cloud, or on any major cloud provider. This adaptability, combined with zero incremental costs for AI pilots allows for rapid scaling of AI use cases and ensures the fastest time-to-value for healthcare providers.
The FDA clearance demonstrates CARPL.ai's dedication to democratizing access to healthcare AI and enabling healthcare systems to confidently and securely deploy AI applications in their practice. By leveraging CARPL.ai’s cutting-edge technology, healthcare providers can achieve exponential clinical, operational, and financial gains by utilizing the encapsulated value of the entire AI ecosystem.
