See how you can connect with your patients at scale.
Bunkerhill Health Secures the First FDA Clearance Enabling Automated Aortic Valve Calcification Quantification on Non-Cardiac Chest CT
SAN FRANCISCO, Jan. 29, 2025 – Bunkerhill Health, a leading provider of healthcare AI solutions, announced today it has achieved FDA clearance for Bunkerhill AVC. Bunkerhill AVC is an AI solution that detects and quantifies aortic valve calcification from non-gated, non-contrast Chest CT. This clearance builds on Bunkerhill Health’s suite of cardiology AI solutions for opportunistic detection of cardiovascular disease.
Calcific aortic valve disease (CAVD) and Aortic Stenosis (AS) are the most prevalent valvular heart condition among the aging population in developed countries. Its disease burden is projected to rise from 2.5 million cases in 2000 to 4.5 million by 2030. Multiple studies have demonstrated that patients with CAVD have high mortality risk across all levels of untreated severity. A study published in the Journal of the American College of Cardiology concluded that patients with moderate or greater AS have a 4-year mortality rate ranging from 33.5% to 45.7%. Unfortunately, AS can progress without noticeable symptoms for an extended period; however, if detected early, prognosis improves significantly.
Bunkerhill AVC is the first FDA-cleared AI solution that detects and quantifies aortic valve calcification on routine CT exams, assisting with early detection and potentially leading to proactive disease management.
Awareness of the Importance of Aortic Valve Calcification with American Medical Societies is Growing
In 2023, the American College of Radiology published an update to recommended Incidental Findings that should be reported in routine Non-Contrast Chest CT/Lung Cancer Screening. Notably, in the final published implementation guide, the American College of Radiology recommends that “Other Abnormalities (such as moderate or greater aortic valve calcification)” be reported incidentally.
Moreover, awareness around the importance of early detection of aortic valve calcification is increasing within the cardiology community. In a recent podcast episode from the American College of Cardiology, key opinion leaders discussed the importance of early detection of aortic valve calcification and summarize implications for how it can positively impact patient care.
Expanding on success of Bunkerhill iCAC, Bunkerhill achieves the First FDA Clearance for Incidental Aortic Valve Calcification Detection
While existing products in the market detect and quantify coronary artery calcification (CAC), Bunkerhill AVC is the first and only FDA-cleared algorithm to gain clearance for the detection and quantification of aortic valve calcification. The timing of the clearance follows a recent wave of evidence in the medical community emphasizing its potential impact.
"Early detection of aortic valve calcification is crucial because patients with aortic stenosis often go undetected until the disease progresses in severity and causes damage to the heart," says Bhavik Patel, Chief Artificial Intelligence Officer at Mayo Clinic Arizona. "The Bunkerhill team has demonstrated their ability to integrate into clinical workflows with iCAC, and I am thrilled about the potential of Bunkerhill AVC to detect these patients opportunistically earlier, enabling proactive management and potentially improving outcomes."
About Bunkerhill Health
Bunkerhill Health is a pioneering healthcare technology company dedicated to transforming patient care through the power of artificial intelligence. With a focus on developing cutting-edge algorithms and scalable solutions, Bunkerhill Health partners with leading healthcare providers and organizations to address critical challenges in medical imaging, diagnostics, and clinical decision-making. By combining technical excellence with a patient-first mindset, Bunkerhill Health strives to improve outcomes, streamline workflows, and advance the global standard of care. For more information, visit www.bunkerhillhealth.com.
