fda-cleared-devices
(3)
AliveCor
AliveCor is a Mountain View, California digital health company that pioneered the personal, FDA-cleared electrocardiogram (ECG). Its Kardia line of pocket-sized devices lets people record a medical-grade ECG on a smartphone in about 30 seconds, while AI algorithms screen for atrial fibrillation and other arrhythmias. Combining hardware, a subscription care service, and enterprise cardiology programs, AliveCor has recorded well over 160 million ECGs for millions of users and works with clinicians, employers, health systems, and pharmaceutical researchers.
Steve Xu
Steve Xu is a board-certified dermatologist turned medtech founder who runs Sibel Health, the Chicago company commercializing ICU-grade wearable sensors that now monitor patients in more than 20 countries. A physician-engineer trained at Rice, Harvard, and the London School of Economics, he splits his life between the clinic, the lab at Northwestern's Querrey Simpson Institute for Bioelectronics, and a startup chasing a single line: Better Health Data for All.
Eric Dy
Eric Dy, PhD is the co-founder and CEO of Bloomlife, a San Francisco-based women's health company building connected care solutions for maternal and fetal monitoring. A biomedical engineer by training (Cornell BSc, UCLA MSc and PhD), Dy spent four years at IMEC - Europe's leading R&D institute - establishing 17 partnerships worth $25M+ in revenue before launching Bloomlife in 2014. His personal experience watching his wife navigate a high-risk pregnancy - gestational diabetes, preeclampsia, placental complications, preterm labor, and a son who spent his first month in the NICU - drove him to attack the most underserved gap in American healthcare. Bloomlife's FDA-cleared MFM-Pro wearable lets high-risk pregnant patients be monitored at home, replacing the endless clinic visits that define the current broken system. The company raised a $12.2M Series A in September 2024 and has secured reimbursement across 18 payers.