software-as-a-medical-device
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The Chicago lab teaching hospitals to read your blood before sepsis reads you
Sepsis kills more Americans than all cancers combined and hides in plain sight. Prenosis spent a decade building a biobank and an algorithm to catch it in the first 24 hours - and got the FDA to say yes.
Mesh Bio
Mesh Bio is a Singapore-based health deep-tech company that uses digital twin technology and predictive analytics to help clinicians detect and manage chronic diseases earlier. Its DARA platform automates health-screening report generation and risk stratification, while HealthVector Diabetes - approved as a Software as a Medical Device by Singapore's Health Sciences Authority - forecasts diabetes complications years before onset. Founded in 2018 by Andrew Wu and Arsen Batagov, the company serves more than 40 healthcare groups across Asia and has assessed over 300,000 patients.
Huma
Huma is a London-based digital health technology company that builds a regulated, modular software platform used by hospitals, pharmaceutical companies and governments to run remote patient monitoring, 'hospital at home', companion apps and decentralized clinical trials. Founded in 2011 as Medopad and rebranded to Huma in 2020, it combines predictive algorithms, digital biomarkers and real-world data with a no-code Huma Cloud Platform so partners can launch regulated, disease- and device-agnostic health apps. Its Software as a Medical Device holds EU MDR Class IIb, US FDA Class II and UK MHRA registrations, and its technology has reached thousands of hospitals and tens of millions of patients worldwide.
Tucuvi
Tucuvi is a clinical voice AI company that builds and operates an AI care management platform for hospitals and health systems. Its voice AI agent, LOLA, safely conducts patient phone conversations, runs clinical and care-coordination workflows such as post-surgical follow-ups and chronic care management, and escalates to human clinicians when needed. Founded in Madrid in 2019 by biomedical engineers Maria Gonzalez Manso and Marcos Rubio, Tucuvi is the first AI platform to earn European Class IIb Software as a Medical Device certification for both its voice agent and its care management platform. It serves more than 60 healthcare organizations across Europe, the UK and the US and has monitored over a million patients.
DexaFit
DexaFit is a health-testing company that turns a quick, low-radiation full-body DXA scan into a broad picture of a person's health - body composition, bone density, visceral fat and metabolic markers. Its AI arm, DexaFit Dx, layers machine learning on top of those same scans to screen for major chronic diseases such as coronary artery disease and type 2 diabetes, aiming to catch them early and non-invasively. Founded in Chicago in 2011 and now operating dozens of centers, DexaFit pairs in-person testing with an app that translates results into longevity scores, disease-risk estimates and trackable goals.
Kaliber Labs
Kaliber Labs is a San Francisco AI research foundry building software that captures rare human expertise - starting in the operating room - and turns it into scalable tools. Trained on one of the world's largest libraries of arthroscopic surgical video and guided by dozens of leading orthopedic surgeons, Kaliber's systems perceive anatomy in real time, automate surgical documentation, and give surgeons, staff, and patients AI that understands what is actually happening inside a procedure.