ce-marked
(3)
Us2.ai
Us2.ai is a Singapore-based medtech company that builds FDA-cleared, CE-marked AI software to automate echocardiography (cardiac ultrasound) analysis and reporting. Its vendor-neutral platform - branded the AI Echo Copilot - turns raw DICOM echo studies into fully editable, structured clinical reports in seconds, detecting conditions such as heart failure, aortic stenosis, pulmonary hypertension and cardiac amyloidosis. Founded in 2017 as eko.ai and rebranded to Us2.ai in 2021, the company aims to widen access to expert-level cardiac diagnostics across hospitals, echo labs and clinical-trial core labs worldwide.
3NT Medical
3NT Medical is an Israeli medical device company building a family of sterile, single-use endoscopes purpose-built for ear, nose, and throat (ENT) surgeons. Its two FDA-cleared, CE-marked products - the Colibri Micro ENT Scope for otology and the Peregrine Drivable ENT Scope for the sinuses - are designed to reach narrow anatomy that rigid reusable scopes struggle to see, while removing the cross-contamination and reprocessing burden of multi-use devices. Founded in 2012 by brothers Ehud and Eran Bendory and backed by Japanese optics maker Hoya, the company operates from Rosh Ha'ayin, Israel, with U.S. operations in Short Hills, New Jersey.
Healthy.io
Healthy.io turns the smartphone camera into a clinical-grade medical device for at-home diagnostics. Founded in Israel in 2013 by Yonatan Adiri, the company uses computer vision, AI and colorimetric analysis to let patients run lab-quality urine tests at home - for kidney disease, urinary tract infections and pregnancy - and gives clinicians AI-powered 3D wound measurement tools. Its flagship Minuteful Kidney test is the first smartphone-powered home test cleared by the FDA to measure the albumin-to-creatinine ratio, and its products are used across US health plans and UK NHS trusts to close gaps in preventative care.