Along with AI in its various iterations, the list may include virtual and augmented reality, 3D printing, robotics and other innovative technologies changing healthcare delivery.
Lazarus 3D: FDA clearance for 3D-printed synthetic soft tissue (July 29)
Lantheus Holdings: FDA clearance for AI molecular imaging prostate cancer assessment (July 29)
Volpara Health: FDA clearance for AI breast density assessment (July 29)
RealView Imaging: FDA clearance for 3D interactive medical holography (Aug. 2)
Abbott: FDA clearance for AI-enhanced coronary artery imaging (Aug. 3)
Neuralert: FDA breakthrough designation for algorithmic inpatient stroke detection (Aug. 3)
InsightRX: CE mark for cloud-based AI precision medication dosing (Aug. 5)
Altoida: FDA breakthrough designation for AI neurocognitive function monitoring/Alzheimer’s prediction (Aug. 5)
Acutus Medical: FDA clearance, CE mark for AI assessment of complex atrial arrhythmias (Aug. 11)
BrainsWay: FDA clearance for deep transcranial magnetic stimulation for anxious depression (Aug. 18)
Qure.ai: FDA clearance for AI brain injury imaging assessment (Aug. 19)
Mauna Kea Technologies: FDA clearance for AI-enhanced blood flow visualization (Aug. 24)