Rochester, Minn.-based Mayo Clinic on Wednesday unveiled two technology companies it co-founded, one of which is seeking regulatory clearance for an artificial-intelligence product.
Both companies are part of a Mayo effort to make it easier for clinicians to glean insights from remote patient-monitoring devices and sensors using AI.
The first company, Anumana, will develop and commercialize AI algorithms for early disease detection. It was founded by Mayo and Nference, a software startup that Mayo is also an investor in. The second company, Lucem Health, was founded with software company Commure to extract and integrate data from medical devices into other software systems.
Anumana, which raised $25.7 million in a Series A funding round led by Mayo and Nference, will apply Nference's AI to Mayo's medical data to create algorithms that detect diseases by reviewing data from sensors. Anumana is starting with a project to detect heart conditions using data from electrocardiogram devices.
Anumana plans to submit data to the Food and Drug Administration later this year in the hopes of receiving clearance for an algorithm that detects low ejection fraction, a sign of heart failure. Dr. Paul Friedman, chair of Mayo's cardiovascular medicine department in Rochester, led the research team that developed the algorithm.
"It's very important for maintaining health to identify things before a bad event happens," Friedman said on a call with reporters.
Anumana has already received breakthrough device designation from the FDA for the algorithm. The FDA's Breakthrough Devices Program, established through the 21st Century Cures Act, involves the agency working closely with companies during the development and review process to guide them on how to establish more efficient clinical study designs to get products approved more quickly.
AI medical devices have been a growing area of focus for the FDA.
The agency late last year opened a digital health center of excellence and in January published a five-pronged plan to underpin its approach to regulating medical software with AI and machine-learning components.
Mayo's second company, Lucem Health, ingests data from remote patient-monitoring devices and connects that data to outside AI algorithms, such as those developed by Anumana or Mayo. The company subsequently integrates insights from those AI algorithms into clinical software systems, such as electronic health records, where clinicians will be able to access the information.
Lucem raised $6 million in a Series A funding round led by Mayo and Commure.
Anumana and Lucem Health support an effort, dubbed the Remote Diagnostics and Management Platform, that Mayo is developing to make it easier for physicians to integrate remote patient-monitoring data into clinical care. The long-term goal is to create clinical decision-support tools that extract recommendations from patient data and present them within clinical workflows, according to Mayo.
"The idea here is to take data and turn it into wisdom," said Dr. John Halamka, president of Mayo Clinic Platform, on a call with reporters.
It's the latest project out of Mayo Clinic Platform, a healthcare technology and big data effort that Mayo unveiled in 2019. Mayo Clinic Platform launched its first project, a clinical data analytics platform that houses de-identified patient data that providers, payers and pharmaceutical companies outside of Mayo can link up to, in January 2020.