For the fourth time in half as many years, Anumana has earned the FDA’s breakthrough device designation for another of its artificial intelligence algorithms designed to catch hard-to-spot heart conditions in their earliest stages.
This time around, the FDA bestowed the label upon Anumana’s algorithm targeting cardiac amyloidosis, a condition in which abnormal tissues build up in and around the heart, making it more difficult for the heart to pump normally and potentially leading to heart failure or even death.
Cardiac amyloidosis can be difficult to properly diagnose because many of its most prevalent symptoms—which include kidney inflammation, liver swelling, heart palpitations and fatigue—may be attributed to other, more common conditions. But Anumana claims to have cracked the code: Its AI tool is designed to pick up on signs of the disease that may otherwise go overlooked by doctors.
Anumana developed the algorithm with support from Pfizer. The duo announced their partnership late last year, pledging to spend the next several years working together to bring the cardiac amyloidosis-spotting tech into clinics in the U.S., Europe and Japan.
Like Anumana’s other AI tools, it works by scouring standard ECGs, digging into the peaks and valleys of the heart’s electrical signals to detect early indicators of the protein build-up that are typically invisible to human doctors.
Next up, the Mayo Clinic and Nference spinout—and recent Fierce 15 honoree—will launch a retrospective clinical trial to validate the algorithm’s real-world ability to spot the condition, all toward the ultimate goal of submitting an application for de novo clearance from the FDA.
With the new breakthrough device label, which Anumana announced Wednesday, that process will be somewhat fast-tracked, as the designation opens up a dedicated channel of communication between the startup and the regulator and also ensures that future applications are shuttled to the top of the agency’s pile for review.
“The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences,” Paul Friedman, M.D., chair of Anumana’s Mayo Clinic board of advisors, said in the announcement. “It is encouraging to see an algorithm that can aid in the identification of cardiac amyloidosis receive breakthrough device designation, as it recognizes the importance of having new tools to detect rare cardiac diseases in ways never before possible.”
Since its founding in 2021, Anumana has racked up breakthrough designations for three other algorithms, all of which task AI with uncovering previously undetectable information from basic ECG readouts. Those algorithms are designed to detect low ejection fraction, hyperkalemia and pulmonary hypertension, the latter of which was developed with support from Janssen.
In the meantime, while pushing those four algorithms closer to FDA clearance, Anumana is still developing a range of other AI tools to help with the early diagnosis of heart conditions. Just last summer, for example, Novartis came aboard to help Anumana build out algorithms that can catch left ventricular dysfunction and atherosclerosis.