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The Philips IVC Filter Removal Laser Sheath - CavaClear - is a highly innovative medical device, specially designed for the removal of embedded IVC filters. It has been granted the Breakthrough Device …
Published Jan 30, 2023 FDA Breakthrough Device Designation
Last Updated
The Univfy Report is a personalized tool that utilizes a scientifically validated model to predict a patient’s probability of success with IVF. The prediction model is customized for each center …
Published Jan 28, 2023 Data
Last Updated
The Spiration Valve System is an endobronchial therapy that is designed for patients with severe emphysema. It offers a minimally invasive treatment option for lung volume reduction and has a …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated
The CUSTOMFLEX® ARTIFICIALIRIS is a foldable iris prosthesis that is used for both medical and aesthetic reconstruction of eyes with complete or partial aniridia. The product is manufactured by …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated
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
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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
Last Updated
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