The CEO of Prenosis told MedTech Dive the company sees third-party validation as important, with the FDA having clarified that certain decision support tools should be regulated as medical devices.
Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam
Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity.
Solution uses fully automated AI segmentation to generate inHEART’s digital twin of the heart with greater speed and efficiency
Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds.
Hologic (Nasdaq: HOLX)+
announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.
MIT CSAIL researchers develop advanced machine-learning models that outperform current methods in detecting pancreatic ductal adenocarcinoma.
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.
Now, an interdisciplinary project at Caltech has designed a new type of catheter tube that impedes the upstream mobility of bacteria, without the need for antibiotics or other chemical antimicrobial methods