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The VideaHealth AI Platform is a dental AI solution that is designed to aid dental chains and providers in their operations. By utilizing AI in X-ray analysis, the platform aims to provide insights …
Published Jan 28, 2023 Dental Care Artificial Intelligence
Last Updated
The Tula System is a medical device that has been approved by the FDA for use in patients aged six months and older. It utilizes a technique called iontophoresis to apply a low-level electrical charge …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated
The Optimizer Smart and its successor, the Optimizer® Smart Mini, are minimally invasive, implantable devices that deliver a proprietary therapy to patients with heart failure. CCM® therapy is a …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated
Koios DS is a software that uses artificial intelligence to analyze ultrasound images and provide cancer risk assessments. The software is built on an ensemble of algorithms that have been trained on …
Published Jan 25, 2023 FDA Breakthrough Device Designation
Last Updated
EYE-SYNC® technology is a tool that measures the synchronization abilities of the eyes. It is designed to identify the quality of performance when interacting with visual cues and synchronizing eye …
Published Jan 25, 2023 FDA Breakthrough Device Designation
Last Updated
Agili-C™ is a cell-free, off-the-shelf implant that is designed to be used in cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is made of a porous, …
Published Jan 25, 2023 FDA Breakthrough Device Designation
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The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is a medical device that is indicated for the low-pressure balloon dilatation of severely calcified, …
Published Jan 24, 2023 FDA Breakthrough Device Designation
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The PoNS device is a medical technology that helps individuals with chronic neurological symptoms caused by disease or trauma. It consists of a controller and a mouthpiece that delivers mild …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The i-STAT Alinity is a portable blood analyzer that uses proven technology from the i-STAT 1 System to deliver real-time, lab-quality diagnostic test results. It features an intuitive interface that …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The IpsiHand is a device designed to assist individuals with chronic stroke in their rehabilitation. It is the first FDA-cleared device that utilizes brain-computer interface technology to improve arm …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
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