de novo clearance
ArteraAI Prostate uses digital pathology images from a patient’s biopsy to predict potential long-term outcomes of their prostate cancer.
The Oxehealth Vital Signs system is installed in a patient's hospital room, where it can spot-measure pulse, heart, respiratory and breathing rates with no physical contact.
The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has greenlit for any condition.
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.