iHealthScreen cleared a crucial FDA hurdle, but can iPredict-DR break AI eye screening’s adoption barrier?
iHealthScreen’s FDA-cleared iPredict-DR brings automated diabetic retinopathy screening closer to primary care, but adoption hurdles remain.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Why the AccurKardia and Wellysis partnership matters for digital cardiology adoption
AccurKardia, Inc. and Wellysis have signed a multi-year agreement to provide a turnkey cardiac monitoring offering for the United States market. The arrangement will pair Wellysis’ S-Patch wearable ECG monitor with AccurKardia’s AccurECG 2.0 automated analytics and reporting software, creating a combined workflow for Holter, extended Holter and mobile cardiac telemetry services. The deal is
Medical Devices & Diagnostics
What iHealthScreen’s iPredict-DR clearance changes for diabetes clinics and primary care
iHealthScreen Inc. has received U.S. Food and Drug Administration 510(k) clearance for iPredict-DR, an AI-powered Software as a Medical Device for automated diabetic retinopathy screening. The retinal imaging software detects more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with the condition, placing the healthcare AI developer into a
Medical Devices & Diagnostics
Why Optellum’s deployment at Tanner Health could matter for lung cancer risk stratification
Find out how Tanner Health’s Optellum rollout could reshape AI lung nodule triage and early lung cancer detection in regional care.
Medical Devices & Diagnostics
Why Sequenex’s MedTech Innovator partnership matters for connected device startups
Medtech startups have sensors, but software can slow them down. Sequenex’s MedTech Innovator tie up targets that commercialization gap.
Medical Devices & Diagnostics
What Anumana’s FDA-cleared pulmonary hypertension algorithm means for cardiovascular AI
Anumana won FDA clearance for an ECG-AI pulmonary hypertension tool. Read what it changes for diagnosis, workflow adoption, and cardiovascular AI strategy.
Medical Devices & Diagnostics
What FDA clearance means for Median Technologies eyonis LCS in a crowded AI radiology market
Median Technologies advances eyonis LCS after FDA clearance. Discover what this means for AI lung cancer screening and European expansion.